Neoplasms
Conditions
Keywords
GSK3745417, Dostarlimab, Anti-Programmed death receptor-1 (PD-1), Monoclonal antibody, Solid tumor, First time in human, Stimulator of Interferon Genes, STING
Brief summary
This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.
Interventions
GSK3745417 will be administered.
Dostarlimab will be administered.
Sponsors
Study design
Masking description
This will be an Open-label study.
Intervention model description
In Part 1A, escalating doses of GSK3745417 will be evaluated and in Part 2A, escalating doses of GSK3745417 in combination with dostarlimab will be evaluated as guided by the Bayesian Logistic Regression Model (BLRM).
Eligibility
Inclusion criteria
* Participant must be more than or equal to (\>=)18 years of age. * Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. * Histological or cytological documentation of an advanced solid tumor. * Participants must provide a fresh biopsy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Adequate organ function per protocol specifications. * Male or female participants. * Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception. * Capable of giving signed informed consent.
Exclusion criteria
* Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years. * Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment. * Current unstable liver or biliary disease. * History of vasculitis at any time prior to study treatment. * Evidence or history of significant active bleeding or coagulation disorder. * Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C. * QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (\>)450 milliseconds (msec) or QTcF \>480 msec for participants with bundle branch block. * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Recent history of allergen desensitization therapy within 4 weeks of starting study treatment. * History or evidence of cardiovascular (CV) risk * Recent (within the past 6 months) history of symptomatic pericarditis. * History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Prior treatment with the following agents: 1. Stimulator of Interferon Genes (STING) agonist at any time. 2. Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter. 3. Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days. 4. Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. * Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed. * Receipt of any live vaccine within 30 days of the start of study treatment. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Major surgery less than or equal to (\<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry. * Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) | Up to 21 Days | AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0 |
| Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W) | Up to 29 Days | AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0 |
| Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Up to 29 Days | AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0 |
| Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Up to 29 Days | AE is DLT if deemed clinically relevant,attributed to study intervention \& met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0 |
| Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | Up to approximately 62 weeks | AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for AE (NCI-CTCAE) (version 5.0):G1=Mild,G2=Moderate,G3=Severe or medically significant but not immediately life-threatening,G4=Life-threatening consequences,G5=Death related AE. |
| Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | Up to approximately 93 weeks | AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE. |
| Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | Up to 30.3 weeks | AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | Week 1 to 6, 9, 10, 12, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | Week 1 to 6, 9, 10, 12, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | Week 1 to 6, 9, 10, 12, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | Pre-dose on W 1, 4, 7, 10, 13, 16, 19; EOI+5min/ 15min/ 30 min/ 45 min/1HR/ 2HR/ 4HR on W 1, 4, 7, 10, 13, 16, 19; EOI+8HR/ 24HR on W 1, 4, 7, 10, 13, 16 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | Week 1, 4, 7, 10, 13, 16, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | Week 1, 4, 7, 10, 13, 16, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | Week 1, 4, 7, 10, 13, 16, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone. |
| Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Pre-dose,EOI+5min/2HR/4HR on W 1 to 5, 7, 10, 13, 19, 37, 55; EOI+15min/ 30min/ 45 min/ 1HR on W 1, 4, 7; EOI+8HR on W 1 to 5, 7, 10, 13, 19; EOI+24HR on W 1 to 5, 7, 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Week 1 to 5, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Week 1 to 5, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Week 1 to 5, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | Pre-dose and EOI+5min/ 2HR/ 4HR on W 1, 2, 5, 6, 8, 11, 14, 20, 38; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1 and 8; EOI+8HR in W 1, 2, 5, 6, 8; EOI+24HR on W 1, 2, 5, 8. | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | Week 1, 2, 5, 6, 8 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | Week 1, 2, 5, 6, 8 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | Week 1, 2, 5, 6, 8 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Pre-dose on W 1, 4, 7, 10, 13, 19, 37, 55, 73, 91; EOI+5min/ 4HR on W 1, 4, 7, 10, 13, 19, 37, 55, 91; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1, 4, 7; EOI+2HR on W 1, 4, 7, 10, 13, 19, 37, 55, 73; EOI+8HR/24 HR on W 1, 4, 7, 10, 13, 19, 91 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Week 1, 4, 7, 10, 13, 19, 91 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Week 1, 4, 7, 10, 13, 19, 91 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Week 1, 4, 7, 10, 13, 19, 91 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Pre-dose and EOI+5min/2HR/ 4HR/ 8HR on crossover W 1, 4, 7, 10, 13, 19; EOI+12HR/18HR on crossover W 4; EOI+15min/ 30 min/45 min/1HR/6HR/24HR on crossover W 1, 4, 7 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Crossover Week 1, 4, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Crossover Week 1, 4, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | Crossover Week 1, 4, 7, 10, 13, 19 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Pre-dose and EOI+5min/ 2HR/4HR on crossover W 1-4, 7,10,19; EOI+15min/30 min/45 min/1HR/ 6HR/ 24HR on crossover W 1,4,7;EOI+12HR/18HR on crossover W 4;EOI+8HR on crossover W 1-4,7,10 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Crossover Week 1, 2, 3, 4, 5, 7, 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Crossover Week 1, 2, 3, 4, 5, 7, 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
| Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | Crossover Week 1, 2, 3, 4, 5, 7, 10 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab. |
Countries
Australia, Canada, France, Japan, Netherlands, South Korea, Spain, United States
Contacts
GlaxoSmithKline
Participant flow
Recruitment details
This study consisted of 2 phases - Dose Escalation (Part 1A and Part 2A) and Dose Expansion (Part 1B and Part 2B). As pre-specified in protocol, dose expansion phases were not conducted following sponsor's decision to cease further enrolment into the study.
Pre-assignment details
The results presented are based on the data cut-off date of 05 Apr 2024. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continued Treatment (PACT) phase and their data will be reported after they stop receiving treatment as per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Part 1A: GSK3745417 0.1 mg (Q3W) Participants with advanced solid tumors received a 0.1 mg dose of GSK3745417 as an intravenous (IV) infusion every three weeks (Q3W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 3 |
| Part 1A: GSK3745417 0.2 mg (Q3W) Participants with advanced solid tumors received a 0.2 mg dose of GSK3745417 as an IV infusion Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 6 |
| Part 1A: GSK3745417 0.1 mg (Q1W) Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion once a week (Q1W) until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 14 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) Japanese participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 2 |
| Part 1A: GSK3745417 0.2 mg (Q1W) Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 19 |
| Part 1A: GSK3745417 0.4 mg (Q1W) Participants with Advanced Solid Tumors received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 10 |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis Participants with Advanced Solid Tumors and effect of prophylaxis received 0.4 mg GSK3745417 as an IV infusion Q1W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 9 |
| Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV every 6 weeks (Q6W) for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 4 |
| Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q3W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 12 |
| Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 4 |
| Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab Participants with Advanced Solid Tumors received 0.1 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through Positron Emission Tomography (PET) imaging of 18F-labeled analog of arabinofuranosyl guanine (\[18F\]F-AraG) and the biodistribution of radiolabeled GSK3745417 were performed. | 3 |
| Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W combination with Dostarlimab 500 mg IV Q3W till Day 85 (Week 13), followed by 1000 mg IV Q6W for subsequent doses until Day 722 or until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. | 10 |
| Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab Participants with Advanced Solid Tumors received 0.2 mg GSK3745417 as an IV infusion Q1W in combination with Dostarlimab 500 mg IV Q3W until disease progression, death, the onset of unacceptable toxicity (including meeting liver chemistry stopping criteria), withdrawal of consent, or upto 2 years, whichever occurred earlier. Additionally, for participants in this arm T-cell activation through PET imaging of \[18F\]F-AraG and the biodistribution of radiolabeled GSK3745417 were performed. | 1 |
| Total | 97 |
Baseline characteristics
| Characteristic | Part 1A: GSK3745417 0.1 mg (Q3W) | Part 1A: GSK3745417 0.2 mg (Q3W) | Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Part 2A: GSK3745417 0.1 mg (Q3W) + Dostarlimab | Part 2A: GSK3745417 0.2 mg (Q3W) + Dostarlimab | Part 2A: GSK3745417 0.1 mg (Q1W) + Dostarlimab | Part 2A: Imaging GSK3745417 0.1 mg (Q1W) + Dostarlimab | Part 2A: GSK3745417 0.2 mg (Q1W) + Dostarlimab | Part 2A: Imaging GSK3745417 0.2 mg (Q1W) + Dostarlimab | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.0 YEARS STANDARD_DEVIATION 1.73 | 46.8 YEARS STANDARD_DEVIATION 17.81 | 55.8 YEARS STANDARD_DEVIATION 11.44 | 66.0 YEARS STANDARD_DEVIATION 2.83 | 56.5 YEARS STANDARD_DEVIATION 15.13 | 53.3 YEARS STANDARD_DEVIATION 11.41 | 51.3 YEARS STANDARD_DEVIATION 9.08 | 66.3 YEARS STANDARD_DEVIATION 5.8 | 55.5 YEARS STANDARD_DEVIATION 12.21 | 54.5 YEARS STANDARD_DEVIATION 7.14 | 61.7 YEARS STANDARD_DEVIATION 12.5 | 58.0 YEARS STANDARD_DEVIATION 10.45 | NA YEARS | 55.5 YEARS STANDARD_DEVIATION 12.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 14 Participants | 2 Participants | 19 Participants | 10 Participants | 9 Participants | 4 Participants | 12 Participants | 4 Participants | 3 Participants | 10 Participants | 1 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 13 Participants | 0 Participants | 19 Participants | 10 Participants | 9 Participants | 3 Participants | 10 Participants | 3 Participants | 0 Participants | 8 Participants | 0 Participants | 84 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 7 Participants | 0 Participants | 9 Participants | 7 Participants | 7 Participants | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 5 Participants | 1 Participants | 50 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 7 Participants | 2 Participants | 10 Participants | 3 Participants | 2 Participants | 0 Participants | 8 Participants | 2 Participants | 3 Participants | 5 Participants | 0 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 5 / 6 | 6 / 14 | 0 / 2 | 14 / 19 | 7 / 10 | 8 / 9 | 3 / 4 | 8 / 12 | 4 / 4 | 2 / 3 | 8 / 10 | 0 / 1 | 0 / 1 | 1 / 4 | 2 / 5 |
| other Total, other adverse events | 2 / 3 | 5 / 6 | 14 / 14 | 2 / 2 | 19 / 19 | 10 / 10 | 9 / 9 | 4 / 4 | 12 / 12 | 4 / 4 | 3 / 3 | 10 / 10 | 1 / 1 | 1 / 1 | 3 / 4 | 5 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 | 4 / 14 | 0 / 2 | 7 / 19 | 3 / 10 | 2 / 9 | 1 / 4 | 6 / 12 | 3 / 4 | 2 / 3 | 4 / 10 | 1 / 1 | 0 / 1 | 1 / 4 | 1 / 5 |
Outcome results
Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Time frame: Up to 30.3 weeks
Population: All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 1 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 1 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 2 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 3 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Crossover Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W)
AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Time frame: Up to 21 Days
Population: DLT Evaluable population included All Treated population who completed at least 21 days of DLT period or discontinued from treatment within 21 days due to an AE meeting the definition of a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 Alone (Q1W) | 2 Participants |
Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W)
AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Time frame: Up to 29 Days
Population: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W) | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants Achieving DLT Following Administration of GSK3745417 Alone (Q3W) | 0 Participants |
Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to National Cancer Institute Common Terminology Criteria for AE (NCI-CTCAE) (version 5.0):G1=Mild,G2=Moderate,G3=Severe or medically significant but not immediately life-threatening,G4=Life-threatening consequences,G5=Death related AE.
Time frame: Up to approximately 62 weeks
Population: All treated population included all participants who received at least one dose of GSK3745417. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 2 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 4 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 1 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 6 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 6 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 5 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 8 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 5 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 5 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 5 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 5 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 3 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 3 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 2 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 5 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) Prophylaxis | Parts 1A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Time frame: Up to 29 Days
Population: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants Achieving DLT Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | 0 Participants |
Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
AE is DLT if deemed clinically relevant,attributed to study intervention & met DLT criteria:CytokineReleaseSyndrome (CRS) (Grade(G) 3/4);Liver Toxicity: ALT≥3xULN + bilirubin≥2xULN/INR\>1.5, ALT≥5x ULN+≥2x baseline with liver,metastases/tumor infiltration or HCC;G≥3 non-hematologic exceptions: Transient lab abnormalities, CRS≤G2,Controlled diarrhea,Resolving nausea/vomiting,Alopecia,G3 fatigue\<7 days,G3 headache resolving in 24 hrs;G≥3 immune-related toxicity unresolved in 8 days despite therapy and G≥3 infusion reactions included;Other toxicities: G≥2 uveitis, Unresolved eye pain/blurred vision in 2 wks,Endocrine toxicity needing hormone replacement,Colitis/diarrhea unresolved for ≥7Days despite steroids,ICANS;Hematologic toxicity includes: Neutropenia(G4 ≥7Days or G3/4 with infection/febrile neutropenia),Thrombocytopenia (G4/G3 with bleeding/transfusion),Anemia (G4/G3 needing transfusion);Other events deemed DLTs by the investigator and GSK Medical Monitor per NCI-CTCAE v5.0
Time frame: Up to 29 Days
Population: DLT Evaluable population included All Treated population who completed at least 29 days of DLT period or discontinued from treatment within 29 days due to an AE meeting the definition of a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants Achieving Dose-limiting Toxicity (DLT) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | 0 Participants |
Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity
AE is any untoward medical occurrence in clinical investigation participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. AEs were graded by the investigator according to NCI-CTCAE v5.0: G1=Mild, G2=Moderate, G3=Severe or medically significant but not immediately life-threatening, G4=Life-threatening consequences, G5=Death related AE.
Time frame: Up to approximately 93 weeks
Population: All treated population. Each participant was counted only once, based on the highest grade they experienced across all adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 1 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 2 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 1 Participants |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 2 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 4 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 1 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 2 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 1 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 2 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 3 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 2 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 3 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 4 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 2 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 2 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 5 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 2 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 1 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 2 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 5 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 1 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 2 | 1 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | STEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 3 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 4 | 0 Participants |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Parts 2A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) by Severity | TEAEs, Grade 5 | 0 Participants |
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 2, 3, 4, 5, 7, 10
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER | 47.4854 h*ng/mL | Geometric Coefficient of Variation 61.409 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER | 119.0544 h*ng/mL | Geometric Coefficient of Variation 129.1524 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER | 152.6791 h*ng/mL | Geometric Coefficient of Variation 93.5753 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER | 45.7777 h*ng/mL | Geometric Coefficient of Variation 183.4279 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 CROSSOVER | 41.5618 h*ng/mL | Geometric Coefficient of Variation 39.4549 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER | 23.9841 h*ng/mL | Geometric Coefficient of Variation 110.4741 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER | 81.4712 h*ng/mL | — |
Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 4, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 1589.8051 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 914.3149 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 3058.1703 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 302.9813 h*ng/mL | Geometric Coefficient of Variation 53.3033 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 979.6423 h*ng/mL | Geometric Coefficient of Variation 32.74 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER | 181.2630 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER | 200.4303 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 193.0653 h*ng/mL | Geometric Coefficient of Variation 68.7457 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER | 201.3292 h*ng/mL | Geometric Coefficient of Variation 46.6743 |
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 2, 3, 4, 5, 7, 10
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER | 18.932 ng/mL | Geometric Coefficient of Variation 64.77 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER | 12.504 ng/mL | Geometric Coefficient of Variation 90.216 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER | 13.412 ng/mL | Geometric Coefficient of Variation 34.669 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER | 15.899 ng/mL | Geometric Coefficient of Variation 60.615 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 CROSSOVER | 22.354 ng/mL | Geometric Coefficient of Variation 19.308 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER | 16.580 ng/mL | Geometric Coefficient of Variation 49.604 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER | 34.700 ng/mL | — |
Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 4, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 25.000 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 10.700 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 28.900 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 46.371 ng/mL | Geometric Coefficient of Variation 38.725 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 39.435 ng/mL | Geometric Coefficient of Variation 24.259 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER | 66.300 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER | 69.700 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 43.381 ng/mL | Geometric Coefficient of Variation 36.411 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER | 47.379 ng/mL | Geometric Coefficient of Variation 17.834 |
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Pre-dose and EOI+5min/ 2HR/4HR on crossover W 1-4, 7,10,19; EOI+15min/30 min/45 min/1HR/ 6HR/ 24HR on crossover W 1,4,7;EOI+12HR/18HR on crossover W 4;EOI+8HR on crossover W 1-4,7,10
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+5MIN | 15.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+15MIN | 14.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+30MIN | 13.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+45MIN | 10.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+1HR | 9.530 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+2HR | 5.780 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+4HR | 2.520 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+6HR | 1.130 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+8HR | 0.507 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER, EOI+5MIN | 20.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER, EOI+2HR | 10.040 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER, EOI+4HR | 3.845 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER, EOI+8HR | 0.968 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER, EOI+5MIN | 17.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER, EOI+2HR | 9.065 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER, EOI+4HR | 5.125 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER, EOI+8HR | 0.826 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+5MIN | 15.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+15MIN | 14.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+30MIN | 12.750 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+45MIN | 11.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+1HR | 10.415 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+2HR | 6.315 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+4HR | 2.325 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+6HR | 0.895 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+8HR | 0.384 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+12HR | 0.248 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+18HR | 0.159 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER, EOI+24HR | 0.055 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+5MIN | 17.500 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+15MIN | 15.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+30MIN | 11.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+45MIN | 9.550 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+1HR | 7.995 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+2HR | 4.415 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+4HR | 1.503 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+6HR | 0.364 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+8HR | 0.199 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER, EOI+5MIN | 34.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER, EOI+2HR | 13.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER, EOI+4HR | 6.430 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER, EOI+8HR | 1.790 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 CROSSOVER, EOI+5MIN | 37.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 CROSSOVER, EOI+2HR | 19.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 CROSSOVER, EOI+4HR | 12.500 ng/mL |
Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Pre-dose and EOI+5min/2HR/ 4HR/ 8HR on crossover W 1, 4, 7, 10, 13, 19; EOI+12HR/18HR on crossover W 4; EOI+15min/ 30 min/45 min/1HR/6HR/24HR on crossover W 1, 4, 7
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, PREDOSE | 8.340 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, PREDOSE | 3.320 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+5MIN | 14.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+5MIN | 25.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+15MIN | 18.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+1HR | 14.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+30MIN | 20.500 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+15MIN | 13.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+45MIN | 17.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+15MIN | 22.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+2HR | 8.290 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+30MIN | 16.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+4HR | 7.130 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+2HR | 10.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+6HR | 11.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+45MIN | 10.500 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+8HR | 4.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+1HR | 16.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+24HR | 3.210 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+1HR | 10.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+4HR | 6.320 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+5MIN | 10.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+2HR | 6.490 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+2HR | 3.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+30MIN | 18.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+4HR | 2.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+4HR | 6.330 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+6HR | 4.780 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, PREDOSE | 3.970 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+6HR | 8.820 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+5MIN | 22.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+5MIN | 28.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+2HR | 9.580 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+8HR | 4.760 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+4HR | 5.140 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+8HR | 6.940 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+12HR | 4.470 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, PREDOSE | 4.110 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+45MIN | 17.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+5MIN | 10.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+18HR | 10.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+2HR | 4.570 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+24HR | 3.780 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+24HR | 2.180 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+5MIN | 56.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+2HR | 21.750 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+4HR | 9.525 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, EOI+8HR | 5.730 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+1HR | 32.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+5MIN | 39.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+15MIN | 40.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+30MIN | 31.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+45MIN | 29.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+1HR | 27.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+2HR | 19.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+4HR | 12.025 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+6HR | 8.885 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+8HR | 2.835 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER, EOI+24HR | 0.327 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+5MIN | 49.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+15MIN | 45.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+30MIN | 38.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+45MIN | 38.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+1HR | 33.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+2HR | 23.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+4HR | 12.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+6HR | 5.740 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+8HR | 4.290 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+12HR | 1.560 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+5MIN | 48.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+18HR | 0.969 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER, EOI+24HR | 0.719 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+15MIN | 40.750 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+30MIN | 37.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+45MIN | 34.450 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+2HR | 23.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+4HR | 12.290 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+6HR | 6.350 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+8HR | 4.740 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER, EOI+24HR | 0.822 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, PREDOSE | 0.085 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+5MIN | 40.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+2HR | 17.950 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+4HR | 9.765 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER, EOI+8HR | 3.665 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+5MIN | 48.150 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+2HR | 29.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+4HR | 15.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER, EOI+8HR | 6.070 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER, PREDOSE | 0.362 ng/mL |
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 2, 3, 4, 5, 7, 10
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 CROSSOVER | 2.1460 Hours | Geometric Coefficient of Variation 66.2957 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 CROSSOVER | 4.7086 Hours | Geometric Coefficient of Variation 327.1693 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 CROSSOVER | 2.1828 Hours | Geometric Coefficient of Variation 54.257 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 CROSSOVER | 3.7809 Hours | Geometric Coefficient of Variation 121.5012 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 CROSSOVER | 1.4489 Hours | Geometric Coefficient of Variation 22.9248 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 CROSSOVER | 1.1078 Hours | Geometric Coefficient of Variation 38.4294 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 CROSSOVER | 1.9742 Hours | — |
Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Crossover Week 1, 4, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 8.6297 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 3336.2317 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 1016.7767 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 CROSSOVER | 23.2987 Hours | Geometric Coefficient of Variation 1163.1768 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 CROSSOVER | 2.2461 Hours | Geometric Coefficient of Variation 10.8792 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 CROSSOVER | 2.1918 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 CROSSOVER | 2.2090 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 CROSSOVER | 15.5839 Hours | Geometric Coefficient of Variation 156.6758 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Crossover Phase: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 CROSSOVER | 8.2823 Hours | Geometric Coefficient of Variation 67.5066 |
Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1 to 6, 9, 10, 12, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 1.7913 Hours | Geometric Coefficient of Variation 68.2418 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK19 | 1.3160 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 3.3936 Hours | Geometric Coefficient of Variation 231.5664 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 3.5628 Hours | Geometric Coefficient of Variation 254.2437 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 2.8077 Hours | Geometric Coefficient of Variation 90.0579 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 3.7449 Hours | Geometric Coefficient of Variation 206.4953 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 4.7658 Hours | Geometric Coefficient of Variation 328.9786 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 2.6641 Hours | Geometric Coefficient of Variation 106.891 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 0.8472 Hours | Geometric Coefficient of Variation 46.5385 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 0.7582 Hours | Geometric Coefficient of Variation 77.8995 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 4.2877 Hours | Geometric Coefficient of Variation 51.4222 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 9.5995 Hours | Geometric Coefficient of Variation 28.9474 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 19.3880 Hours | Geometric Coefficient of Variation 469.4324 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 2.6123 Hours | Geometric Coefficient of Variation 174.1372 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 3.2869 Hours | Geometric Coefficient of Variation 68.0644 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 1.1755 Hours | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 3.9070 Hours | Geometric Coefficient of Variation 210.2296 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 2.9851 Hours | Geometric Coefficient of Variation 142.5006 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 3.4171 Hours | Geometric Coefficient of Variation 154.747 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 3.3057 Hours | Geometric Coefficient of Variation 155.8241 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 3.6380 Hours | Geometric Coefficient of Variation 215.0417 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 2.8734 Hours | Geometric Coefficient of Variation 146.349 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 1.5753 Hours | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 0.8903 Hours | Geometric Coefficient of Variation 52.3388 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 2.0752 Hours | Geometric Coefficient of Variation 137.0553 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 1.9345 Hours | Geometric Coefficient of Variation 128.5751 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 1.1873 Hours | Geometric Coefficient of Variation 30.5239 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 2.1743 Hours | Geometric Coefficient of Variation 110.6625 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 1.6793 Hours | Geometric Coefficient of Variation 100.7945 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 1.8997 Hours | Geometric Coefficient of Variation 167.2107 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 1.3649 Hours | Geometric Coefficient of Variation 73.8778 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 1.9482 Hours | Geometric Coefficient of Variation 136.5929 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 5.8372 Hours | Geometric Coefficient of Variation 277.8089 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 3.1452 Hours | Geometric Coefficient of Variation 31.5377 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 3.0618 Hours | Geometric Coefficient of Variation 71.7607 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 5.4240 Hours | Geometric Coefficient of Variation 106.1862 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 1.9083 Hours | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 3.1800 Hours | Geometric Coefficient of Variation 29.9556 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 1.5023 Hours | Geometric Coefficient of Variation 73.2964 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Apparent Terminal Phase Half-life (t1/2) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 3.6785 Hours | Geometric Coefficient of Variation 30.4604 |
Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1 to 6, 9, 10, 12, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 47.0402 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 73.0706 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK19 | 28.6164 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 39.0336 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 35.7876 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 18.8752 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 55.5837 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 19.8179 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 61.7906 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 46.2111 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 126.0831 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 69.7018 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 102.851 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 77.8444 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 108.544 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 46.6175 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 103.714 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 38.6047 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 101.8073 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 425.3023 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 189.71 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 338.2702 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 96.4149 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 285.9155 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 118.7575 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 173.6723 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 38.7832 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 63.1059 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 377.1988 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 79.7311 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 133.7003 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 132.4949 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 149.6756 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 122.4637 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 138.8428 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 132.3027 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 133.8118 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 145.6088 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 111.8033 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 130.5975 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 114.5345 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 150.3281 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 116.4078 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 84.7136 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 35.4645 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 245.7313 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 103.6711 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 304.3914 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 139.3329 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 272.8593 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 127.8989 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 246.7692 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 132.0408 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 318.5676 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 115.5291 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 276.5512 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 116.8407 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 297.4580 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 137.6797 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 199.9995 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 61.2526 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 198.6138 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 70.3728 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 203.4746 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 53.4979 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 216.6902 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 91.1146 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 255.0798 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 175.7315 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 63.3206 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 247.2823 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 79.1154 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 234.0111 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 85.9781 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Area Under the Concentration-time Curve (AUC0-tau) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 253.8358 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 103.5394 |
Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1, 4, 7, 10, 13, 16, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 113.1657 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 7.851 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 87.6701 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 97.5597 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 108.6757 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 46.0604 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 24.5659 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 55.1481 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 20.7267 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 80.1101 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 3.0157 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK19 | 47.0437 Hours*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 145.2959 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 49.6241 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 160.3952 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 60.7743 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 120.1116 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 37.5649 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 96.6895 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 103.2832 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 227.9506 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 144.4144 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: AUC(0-tau) Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 262.4978 Hours*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 16.2226 |
Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1, 4, 7, 10, 13, 16, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK19 | 24.762 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 15.437 ng/mL | Geometric Coefficient of Variation 49.771 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 20.703 ng/mL | Geometric Coefficient of Variation 19.236 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 20.823 ng/mL | Geometric Coefficient of Variation 33.402 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 20.319 ng/mL | Geometric Coefficient of Variation 28.639 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 11.616 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 17.549 ng/mL | Geometric Coefficient of Variation 32.677 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 52.759 ng/mL | Geometric Coefficient of Variation 3.691 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 79.308 ng/mL | Geometric Coefficient of Variation 21.611 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 53.302 ng/mL | Geometric Coefficient of Variation 46.526 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 66.892 ng/mL | Geometric Coefficient of Variation 24.171 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 56.320 ng/mL | Geometric Coefficient of Variation 30.48 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Cmax Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 67.238 ng/mL | Geometric Coefficient of Variation 38.878 |
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Pre-dose on weeks(W) 1-6,9,10,12,19,55;end of infusion(EOI)+5minute(min) on W 1-6, 9,10,12,19,55;EOI+4 hour(HR)/8 HR on W 1-6, 9, 10, 12, 19;EOI+15min/30min/45min/1HR on W 1-6, 9,12;EOI+24HR on W 1-6, 9,10,12; EOI+2HR on W 1-6,9,10,12,19,55
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom at least one PK sample was obtained and analyzed. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+4HR | 2.970 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+30MIN | 14.750 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+2HR | 6.210 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+5MIN | 20.740 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+1HR | 21.055 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+45MIN | 13.150 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+8HR | 0.473 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+15MIN | 16.120 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+8HR | 0.462 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+5MIN | 18.575 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+24HR | 0.054 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK55, EOI+2HR | 5.510 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+5MIN | 22.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+30MIN | 16.800 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+1HR | 12.510 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+45MIN | 13.380 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK55, EOI+5MIN | 13.500 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+5MIN | 21.365 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+45MIN | 14.090 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+2HR | 6.990 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+4HR | 1.850 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+24HR | 0.268 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+1HR | 11.400 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+15MIN | 20.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+8HR | 0.391 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+8HR | 0.462 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+2HR | 10.020 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+45MIN | 23.095 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+5MIN | 19.480 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+4HR | 2.205 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+8HR | 0.381 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+15MIN | 17.260 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+15MIN | 21.110 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+4HR | 2.490 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+30MIN | 15.290 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+2HR | 7.880 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+2HR | 7.370 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+5MIN | 23.550 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+4HR | 1.620 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+8HR | 0.397 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+8HR | 0.195 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+45MIN | 12.550 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+30MIN | 16.790 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+4HR | 2.030 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+1HR | 11.950 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+1HR | 5.325 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+2HR | 6.090 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+2HR | 5.930 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+1HR | 10.580 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+4HR | 2.085 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+5MIN | 17.250 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+45MIN | 15.735 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK55, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+8HR | 0.409 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+15MIN | 18.880 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+4HR | 1.540 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+8HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+2HR | 5.280 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+15MIN | 20.720 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+5MIN | 19.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+2HR | 3.205 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+4HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+4HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+1HR | 14.545 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+2HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+1HR | 7.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+24HR | 0.067 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+45MIN | 8.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+30MIN | 11.570 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+45MIN | 11.150 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+15MIN | 17.340 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+5MIN | 22.990 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+5MIN | 24.245 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+30MIN | 16.215 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+15MIN | 27.620 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+30MIN | 15.800 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+30MIN | 25.495 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+8HR | 17.930 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+8HR | 3.470 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, PREDOSE | 0.665 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+24HR | 0.791 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+4HR | 24.690 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+5MIN | 27.850 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+5MIN | 15.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+2HR | 34.100 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+5MIN | 9.390 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+1HR | 21.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+2HR | 8.460 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+2HR | 11.500 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+5MIN | 27.400 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+2HR | 13.400 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+30MIN | 17.050 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+4HR | 6.190 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+2HR | 14.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+4HR | 7.400 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+2HR | 24.100 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+8HR | 2.840 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+4HR | 18.800 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+24HR | 3.460 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+4HR | 8.605 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+5MIN | 21.350 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+5MIN | 21.350 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+8HR | 5.480 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, EOI+5MIN | 42.400 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+45MIN | 14.365 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+5MIN | 18.650 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK19, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+4HR | 8.010 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+4HR | 7.320 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+24HR | 1.020 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+8HR | 4.020 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+15MIN | 18.590 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+2HR | 14.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+4HR | 5.072 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+24HR | 0.516 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+2HR | 12.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+24HR | 0.856 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+8HR | 0.746 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+15MIN | 40.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+45MIN | 31.420 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+2HR | 16.200 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+5MIN | 49.810 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+15MIN | 45.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+30MIN | 36.370 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+45MIN | 31.750 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+1HR | 31.230 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+5MIN | 49.010 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+15MIN | 44.120 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+30MIN | 36.790 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+1HR | 32.030 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+8HR | 0.236 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+30MIN | 33.500 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+45MIN | 31.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+2HR | 17.320 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+4HR | 7.620 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+8HR | 0.129 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+5MIN | 47.173 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+15MIN | 42.492 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+1HR | 25.885 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+2HR | 14.350 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+30MIN | 32.860 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+45MIN | 28.320 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+1HR | 30.325 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+2HR | 17.485 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+4HR | 7.630 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+15MIN | 46.830 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+4HR | 3.020 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+5MIN | 66.540 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+2HR | 13.405 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+4HR | 2.650 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+5MIN | 44.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+30MIN | 36.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+1HR | 29.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+4HR | 6.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+8HR | 0.338 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+2HR | 15.695 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+4HR | 8.150 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+8HR | 0.438 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+45MIN | 34.510 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+2HR | 17.600 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+4HR | 8.480 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+5MIN | 49.095 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+15MIN | 41.540 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+1HR | 28.030 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+30MIN | 33.345 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+45MIN | 27.900 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+4HR | 5.495 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+5MIN | 58.328 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+15MIN | 37.845 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+8HR | 1.642 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+24HR | 0.201 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+5MIN | 43.295 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+30MIN | 38.160 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+45MIN | 30.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+1HR | 25.965 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+2HR | 14.675 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, PREDOSE | 3.150 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+5MIN | 71.450 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+2HR | 38.650 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+4HR | 25.150 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK10, EOI+8HR | 2.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+15MIN | 47.080 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+30MIN | 41.385 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+45MIN | 29.580 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+1HR | 24.850 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+8HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+5MIN | 106.260 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+5MIN | 101.655 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+15MIN | 121.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+4HR | 13.200 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+15MIN | 106.120 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+1HR | 63.890 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+5MIN | 119.990 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+8HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+15MIN | 99.440 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+30MIN | 90.085 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+8HR | 20.940 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+45MIN | 85.550 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+15MIN | 97.570 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+15MIN | 132.160 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+4HR | 10.710 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+5MIN | 126.020 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+1HR | 66.970 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+30MIN | 92.780 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+45MIN | 76.765 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+30MIN | 108.240 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+4HR | 17.490 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+5MIN | 103.550 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+45MIN | 85.520 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+30MIN | 85.740 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+2HR | 47.890 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+30MIN | 111.920 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+1HR | 75.860 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+2HR | 31.510 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+1HR | 73.750 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+4HR | 19.080 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+45MIN | 92.490 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+24HR | 6.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+2HR | 64.050 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+15MIN | 99.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+1HR | 72.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+2HR | 41.550 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+5MIN | 150.260 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+4HR | 20.740 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+30MIN | 92.590 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+15MIN | 116.030 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+8HR | 6.120 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+5MIN | 113.140 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+2HR | 36.110 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+30MIN | 83.075 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+2HR | 45.560 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+2HR | 41.620 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+45MIN | 70.485 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+1HR | 62.310 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+1HR | 76.440 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+2HR | 32.970 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+8HR | 8.370 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+45MIN | 89.030 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+45MIN | 87.250 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+4HR | 11.380 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+30MIN | 78.930 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+45MIN | 79.810 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+8HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+4HR | 14.945 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+1HR | 69.760 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+8HR | 2.845 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+4HR | 23.080 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+15MIN | 90.640 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, PREDOSE | 5.130 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+5MIN | 106.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+2HR | 49.617 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+1HR | 69.849 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+1HR | 74.026 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+15MIN | 94.482 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+30MIN | 80.173 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+2HR | 50.148 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+5MIN | 112.617 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+4HR | 20.212 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+5MIN | 121.546 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+30MIN | 85.103 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+15MIN | 94.602 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+45MIN | 69.923 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+24HR | 0.686 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+2HR | 32.906 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+8HR | 2.564 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+4HR | 14.279 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+5MIN | 111.450 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+5MIN | 112.175 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+4HR | 13.288 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+15MIN | 102.480 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+45MIN | 68.947 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+45MIN | 78.505 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+1HR | 64.737 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+2HR | 38.423 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+24HR | 0.700 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+30MIN | 76.850 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+5MIN | 111.655 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+45MIN | 70.156 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, EOI+30MIN | 90.573 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+8HR | 2.599 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+24HR | 0.752 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+24HR | 0.459 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+8HR | 1.944 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+5MIN | 102.851 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+1HR | 56.589 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+4HR | 3.917 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+30MIN | 78.439 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+8HR | 0.935 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, EOI+15MIN | 104.424 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+24HR | 0.269 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, PREDOSE | 0.145 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK3, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+15MIN | 86.184 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+5MIN | 98.752 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+24HR | 1.129 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+15MIN | 96.102 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+30MIN | 83.767 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+45MIN | 80.187 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+8HR | 7.987 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+1HR | 70.788 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+2HR | 38.384 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+4HR | 28.923 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+1HR | 61.492 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+5MIN | 98.041 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+4HR | 37.657 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+15MIN | 90.104 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK12, EOI+30MIN | 85.491 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+2HR | 15.285 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+45MIN | 66.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+1HR | 40.026 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK9, EOI+2HR | 48.390 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+1HR | 59.051 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+2HR | 39.142 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+45MIN | 47.588 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK2, EOI+45MIN | 75.977 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+4HR | 12.886 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+30MIN | 62.879 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK1, EOI+8HR | 2.200 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK6, EOI+15MIN | 86.413 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q1W) | WEEK5, EOI+4HR | 22.082 Nanogram/ millilitre (ng/mL) |
Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Pre-dose on W 1, 4, 7, 10, 13, 16, 19; EOI+5min/ 15min/ 30 min/ 45 min/1HR/ 2HR/ 4HR on W 1, 4, 7, 10, 13, 16, 19; EOI+8HR/ 24HR on W 1, 4, 7, 10, 13, 16
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+45MIN | 6.717 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+8HR | 1.306 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+24HR | 0.224 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+5MIN | 16.300 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+5MIN | 11.616 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+1HR | 6.132 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+2HR | 3.484 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+8HR | 0.380 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+24HR | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+5MIN | 20.721 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+15MIN | 18.115 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+30MIN | 16.677 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+45MIN | 14.784 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+1HR | 12.920 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+2HR | 9.099 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+4HR | 5.529 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+8HR | 1.455 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+24HR | 0.284 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+5MIN | 24.762 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+15MIN | 20.382 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+30MIN | 19.166 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+45MIN | 15.938 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+1HR | 13.778 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+2HR | 7.581 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+4HR | 4.616 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+5MIN | 19.656 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+15MIN | 17.848 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+30MIN | 16.010 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+45MIN | 14.122 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+1HR | 12.503 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+2HR | 8.103 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+24HR | 0.213 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+5MIN | 19.178 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+15MIN | 19.738 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+30MIN | 17.016 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+45MIN | 15.065 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+1HR | 14.628 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+2HR | 9.483 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+4HR | 3.133 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+8HR | 1.067 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+24HR | 0.172 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+5MIN | 17.996 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+15MIN | 15.603 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+30MIN | 16.050 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+45MIN | 14.383 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+1HR | 13.182 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+2HR | 8.885 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+4HR | 4.126 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+8HR | 1.730 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+15MIN | 14.881 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+30MIN | 14.029 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+45MIN | 12.552 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+1HR | 10.926 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+2HR | 6.899 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+4HR | 3.349 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+8HR | 1.178 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+24HR | 0.186 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+15MIN | 9.839 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+30MIN | 8.136 Nanogram/ millilitre (ng/mL) |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+4HR | 4.324 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+30MIN | 52.583 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+15MIN | 59.686 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+4HR | 5.024 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+15MIN | 51.354 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+8HR | 0.867 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+24HR | 0.162 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+30MIN | 48.956 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+30MIN | 45.104 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+24HR | 0.249 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+45MIN | 41.514 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+30MIN | 43.613 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+5MIN | 72.010 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+1HR | 32.591 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+45MIN | 53.366 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+5MIN | 52.322 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+45MIN | 42.186 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+2HR | 14.133 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+1HR | 39.095 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+45MIN | 34.381 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+2HR | 25.151 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+4HR | 15.093 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+24HR | 0.390 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+8HR | 5.522 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+8HR | 2.970 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+24HR | 1.165 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+1HR | 30.738 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+5MIN | 52.777 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+5MIN | 79.138 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+15MIN | 37.137 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+1HR | 44.280 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+30MIN | 25.695 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+15MIN | 60.396 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+45MIN | 25.281 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+2HR | 17.308 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+1HR | 18.798 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+30MIN | 42.864 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+2HR | 13.221 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK13, EOI+15MIN | 54.481 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+4HR | 5.104 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+45MIN | 36.750 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+8HR | 1.806 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+4HR | 4.005 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK16, EOI+24HR | 0.297 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+1HR | 31.770 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+2HR | 29.161 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+5MIN | 48.719 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+2HR | 14.780 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+15MIN | 41.813 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+8HR | 0.978 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+30MIN | 33.774 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+4HR | 2.769 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+45MIN | 28.790 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+24HR | 0.667 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+1HR | 22.454 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK4, EOI+8HR | 0.712 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+2HR | 21.388 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+15MIN | 59.605 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK19, EOI+4HR | 10.894 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK10, EOI+4HR | 14.945 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, PREDOSE | 0.000 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK7, EOI+5MIN | 56.701 Nanogram/ millilitre (ng/mL) |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 Alone (Q3W) | WEEK1, EOI+5MIN | 68.092 Nanogram/ millilitre (ng/mL) |
Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1 to 6, 9, 10, 12, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK19 | 15.700 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 20.791 ng/mL | Geometric Coefficient of Variation 57.142 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 17.284 ng/mL | Geometric Coefficient of Variation 38.137 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 21.648 ng/mL | Geometric Coefficient of Variation 44.92 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 24.710 ng/mL | Geometric Coefficient of Variation 33.028 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 25.079 ng/mL | Geometric Coefficient of Variation 47.896 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 18.057 ng/mL | Geometric Coefficient of Variation 42.913 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 19.956 ng/mL | Geometric Coefficient of Variation 44.055 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 18.972 ng/mL | Geometric Coefficient of Variation 61.73 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 24.213 ng/mL | Geometric Coefficient of Variation 8.391 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 20.669 ng/mL | Geometric Coefficient of Variation 37.429 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 39.421 ng/mL | Geometric Coefficient of Variation 40.108 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 6.152 ng/mL | Geometric Coefficient of Variation 248.49 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 19.922 ng/mL | Geometric Coefficient of Variation 59.477 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 27.442 ng/mL | Geometric Coefficient of Variation 24.724 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 47.747 ng/mL | Geometric Coefficient of Variation 66.571 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 53.434 ng/mL | Geometric Coefficient of Variation 38.959 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 46.712 ng/mL | Geometric Coefficient of Variation 50.725 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 49.458 ng/mL | Geometric Coefficient of Variation 38.252 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 51.851 ng/mL | Geometric Coefficient of Variation 84.399 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 128.974 ng/mL | Geometric Coefficient of Variation 71.075 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 50.470 ng/mL | Geometric Coefficient of Variation 34.755 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 43.320 ng/mL | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK10 | 72.100 ng/mL | — |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 120.172 ng/mL | Geometric Coefficient of Variation 25.81 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 115.067 ng/mL | Geometric Coefficient of Variation 21.459 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 114.148 ng/mL | Geometric Coefficient of Variation 27.392 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 112.085 ng/mL | Geometric Coefficient of Variation 26.349 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 118.978 ng/mL | Geometric Coefficient of Variation 21.611 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 151.763 ng/mL | Geometric Coefficient of Variation 34.837 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 119.378 ng/mL | Geometric Coefficient of Variation 46.814 |
| Part 1A: GSK3745417 0.4 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 116.290 ng/mL | Geometric Coefficient of Variation 35.137 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK1 | 115.244 ng/mL | Geometric Coefficient of Variation 24.732 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK4 | 125.171 ng/mL | Geometric Coefficient of Variation 30.301 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK2 | 111.111 ng/mL | Geometric Coefficient of Variation 31.847 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK12 | 116.269 ng/mL | — |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK5 | 117.339 ng/mL | Geometric Coefficient of Variation 20.709 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK9 | 111.267 ng/mL | Geometric Coefficient of Variation 25.162 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK6 | 111.399 ng/mL | Geometric Coefficient of Variation 13.175 |
| Part 1A: GSK3745417 0.2 mg (Q1W) | Part 1A: Maximum Observed Concentration (Cmax) Following Administration of GSK3745417 Alone (Q1W) | WEEK3 | 103.552 ng/mL | Geometric Coefficient of Variation 24.989 |
Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 alone.
Time frame: Week 1, 4, 7, 10, 13, 16, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 3.8978 Hours | Geometric Coefficient of Variation 37.0772 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 3.0907 Hours | Geometric Coefficient of Variation 64.7708 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 1.6765 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 3.5409 Hours | Geometric Coefficient of Variation 35.5513 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK19 | 1.4041 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 4.3622 Hours | Geometric Coefficient of Variation 8.6103 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 3.3703 Hours | Geometric Coefficient of Variation 8.6696 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK1 | 3.3373 Hours | Geometric Coefficient of Variation 26.781 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK16 | 2.3492 Hours | Geometric Coefficient of Variation 146.8761 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK10 | 4.0823 Hours | Geometric Coefficient of Variation 26.7208 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK7 | 7.5933 Hours | Geometric Coefficient of Variation 703.4471 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK13 | 4.7440 Hours | Geometric Coefficient of Variation 42.2168 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 1A: T1/2 Following Administration of GSK3745417 Alone (Q3W) | WEEK4 | 3.2810 Hours | Geometric Coefficient of Variation 97.7614 |
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 2, 5, 6, 8
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 48.4490 h*ng/mL | Geometric Coefficient of Variation 7.7001 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 35.1903 h*ng/mL | Geometric Coefficient of Variation 67.655 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 44.6483 h*ng/mL | Geometric Coefficient of Variation 53.3204 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1 | 61.7410 h*ng/mL | Geometric Coefficient of Variation 41.638 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 50.7155 h*ng/mL | Geometric Coefficient of Variation 51.4681 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 187.0690 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 561.8580 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 262.5058 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 163.2896 h*ng/mL | — |
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1 to 5, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 216.7790 h*ng/mL | Geometric Coefficient of Variation 129.0498 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 271.1541 h*ng/mL | Geometric Coefficient of Variation 167.9069 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 105.7925 h*ng/mL | Geometric Coefficient of Variation 37.9802 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 69.6510 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 326.3424 h*ng/mL | Geometric Coefficient of Variation 105.6259 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 87.5461 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 43.3152 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 93.7275 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 171.3085 h*ng/mL | Geometric Coefficient of Variation 31.4407 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 | 476.8171 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 128.9958 h*ng/mL | Geometric Coefficient of Variation 39.4126 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 216.5303 h*ng/mL | Geometric Coefficient of Variation 118.842 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 471.1217 h*ng/mL | Geometric Coefficient of Variation 96.1181 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 310.4697 h*ng/mL | Geometric Coefficient of Variation 81.1473 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 130.8498 h*ng/mL | Geometric Coefficient of Variation 76.6372 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 130.9849 h*ng/mL | Geometric Coefficient of Variation 80.5132 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 122.3525 h*ng/mL | Geometric Coefficient of Variation 31.6306 |
Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 4, 7, 10, 13, 19, 91
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91 | 31.1811 h*ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 41.2241 h*ng/mL | Geometric Coefficient of Variation 46.826 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 42.0297 h*ng/mL | Geometric Coefficient of Variation 92.4823 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 44.0290 h*ng/mL | Geometric Coefficient of Variation 208.4637 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 103.5186 h*ng/mL | Geometric Coefficient of Variation 400.0481 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 | 189.3316 h*ng/mL | Geometric Coefficient of Variation 16.9323 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 217.9598 h*ng/mL | Geometric Coefficient of Variation 148.0574 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 | 539.0039 h*ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 136.9391 h*ng/mL | Geometric Coefficient of Variation 91.3047 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 283.2979 h*ng/mL | Geometric Coefficient of Variation 364.42 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: AUC(0-tau) Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 110.3856 h*ng/mL | Geometric Coefficient of Variation 83.9274 |
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 2, 5, 6, 8
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 15.326 ng/mL | Geometric Coefficient of Variation 18.09 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 12.552 ng/mL | Geometric Coefficient of Variation 29.984 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 18.860 ng/mL | Geometric Coefficient of Variation 10.751 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1 | 19.695 ng/mL | Geometric Coefficient of Variation 2.817 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 12.429 ng/mL | Geometric Coefficient of Variation 39.182 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 64.400 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 18.700 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 82.500 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 53.000 ng/mL | — |
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1 to 5, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 16.300 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 25.829 ng/mL | Geometric Coefficient of Variation 11.287 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 17.709 ng/mL | Geometric Coefficient of Variation 44.248 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 20.725 ng/mL | Geometric Coefficient of Variation 16.041 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 29.271 ng/mL | Geometric Coefficient of Variation 35.456 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 19.600 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 38.000 ng/mL | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 22.100 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 51.623 ng/mL | Geometric Coefficient of Variation 17.632 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 41.366 ng/mL | Geometric Coefficient of Variation 31.911 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 49.347 ng/mL | Geometric Coefficient of Variation 27.385 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 42.791 ng/mL | Geometric Coefficient of Variation 19.418 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 51.212 ng/mL | Geometric Coefficient of Variation 31.808 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 | 42.900 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 40.056 ng/mL | Geometric Coefficient of Variation 72.883 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 50.660 ng/mL | Geometric Coefficient of Variation 10.597 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 44.277 ng/mL | Geometric Coefficient of Variation 29.284 |
Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 4, 7, 10, 13, 19, 91
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 23.184 ng/mL | Geometric Coefficient of Variation 13.852 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 24.297 ng/mL | Geometric Coefficient of Variation 5.545 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 23.179 ng/mL | Geometric Coefficient of Variation 29.068 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 25.904 ng/mL | Geometric Coefficient of Variation 25.29 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91 | 19.900 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 38.655 ng/mL | Geometric Coefficient of Variation 20.087 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 | 112.000 ng/mL | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 42.961 ng/mL | Geometric Coefficient of Variation 26.296 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 29.947 ng/mL | Geometric Coefficient of Variation 33.758 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 42.936 ng/mL | Geometric Coefficient of Variation 20.005 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: Cmax Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 | 50.528 ng/mL | Geometric Coefficient of Variation 25.89 |
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Pre-dose and EOI+5min/ 2HR/ 4HR on W 1, 2, 5, 6, 8, 11, 14, 20, 38; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1 and 8; EOI+8HR in W 1, 2, 5, 6, 8; EOI+24HR on W 1, 2, 5, 8.
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+8HR | 0.374 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+4HR | 2.140 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+8HR | 0.425 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+5MIN | 14.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+2HR | 6.910 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+24HR | 0.144 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+2HR | 7.790 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+4HR | 3.430 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+8HR | 1.500 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+15MIN | 17.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+30MIN | 14.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+45MIN | 11.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+1HR | 10.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+2HR | 6.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+4HR | 1.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+6HR | 1.040 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+8HR | 0.626 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+5MIN | 15.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+2HR | 8.790 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+4HR | 4.910 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+5MIN | 10.990 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+2HR | 7.010 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+4HR | 2.515 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK20, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK20, EOI+5MIN | 19.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK20, EOI+2HR | 11.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK20, EOI+4HR | 6.390 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK38, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK38, EOI+5MIN | 19.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK38, EOI+2HR | 6.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK38, EOI+4HR | 2.030 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+5MIN | 12.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+4HR | 3.750 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+8HR | 1.440 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+5MIN | 17.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+5MIN | 18.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+5MIN | 19.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+15MIN | 19.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+30MIN | 15.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+45MIN | 13.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+1HR | 11.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+2HR | 8.360 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+4HR | 2.290 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+6HR | 0.838 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, EOI+24HR | 0.204 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+2HR | 5.930 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, PREDOSE | 0.464 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+24HR | 0.571 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+2HR | 28.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+2HR | 29.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+4HR | 15.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+6HR | 7.130 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+2HR | 27.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+5MIN | 53.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+5MIN | 56.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+4HR | 13.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+8HR | 5.170 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6, EOI+8HR | 5.670 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+4HR | 14.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+5MIN | 64.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+24HR | 0.548 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+15MIN | 52.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+4HR | 6.850 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+30MIN | 50.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+5MIN | 18.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+45MIN | 43.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+2HR | 17.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+1HR | 40.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+8HR | 16.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK11, EOI+5MIN | 68.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2, EOI+24HR | 9.210 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+2HR | 26.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+5MIN | 82.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK14, EOI+2HR | 12.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5, EOI+8HR | 5.740 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8, EOI+4HR | 11.900 ng/mL |
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Pre-dose,EOI+5min/2HR/4HR on W 1 to 5, 7, 10, 13, 19, 37, 55; EOI+15min/ 30min/ 45 min/ 1HR on W 1, 4, 7; EOI+8HR on W 1 to 5, 7, 10, 13, 19; EOI+24HR on W 1 to 5, 7, 10
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+2HR | 14.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+4HR | 10.105 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+2HR | 17.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+2HR | 18.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+4HR | 12.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+5MIN | 22.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+8HR | 6.470 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+5MIN | 22.550 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+2HR | 9.220 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+4HR | 8.610 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+4HR | 5.110 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+45MIN | 21.150 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+15MIN | 23.150 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+1HR | 23.850 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+8HR | 5.105 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+8HR | 4.275 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+30MIN | 20.450 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+24HR | 0.675 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+8HR | 1.140 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+45MIN | 17.550 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+5MIN | 16.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+5MIN | 27.950 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+2HR | 10.375 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+1HR | 18.050 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+4HR | 5.670 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+2HR | 6.990 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+8HR | 2.484 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+2HR | 12.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+4HR | 7.735 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+5MIN | 19.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+15MIN | 19.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+4HR | 3.090 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+30MIN | 15.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+8HR | 2.580 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+45MIN | 12.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+15MIN | 24.950 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+1HR | 10.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+24HR | 0.390 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+8HR | 0.463 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+5MIN | 38.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+5MIN | 26.350 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+2HR | 9.940 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+5MIN | 19.250 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+4HR | 4.570 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+30MIN | 25.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+8HR | 0.782 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+24HR | 0.677 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+5MIN | 45.250 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+2HR | 19.050 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+4HR | 8.720 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+8HR | 3.130 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5, EOI+24HR | 0.719 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+15MIN | 40.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+30MIN | 36.750 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+45MIN | 32.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+1HR | 29.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+24HR | 0.528 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+5MIN | 49.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+2HR | 17.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+4HR | 6.710 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+8HR | 4.840 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+4HR | 15.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+8HR | 9.830 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+24HR | 3.915 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+5MIN | 49.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+5MIN | 39.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+15MIN | 35.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+2HR | 19.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+4HR | 10.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+5MIN | 45.950 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+2HR | 18.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+4HR | 8.515 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7, EOI+8HR | 2.340 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10, EOI+24HR | 0.250 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+5MIN | 49.950 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+2HR | 22.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+4HR | 10.120 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK55, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK55, EOI+5MIN | 123.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK55, EOI+2HR | 10.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13, EOI+8HR | 4.825 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19, EOI+5MIN | 44.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19, EOI+2HR | 17.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19, EOI+4HR | 6.090 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19, EOI+8HR | 21.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK37, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK37, EOI+5MIN | 51.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK37, EOI+2HR | 16.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK37, EOI+4HR | 6.150 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK55, EOI+4HR | 3.310 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+5MIN | 54.750 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+15MIN | 50.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+30MIN | 43.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+45MIN | 39.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+1HR | 34.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+2HR | 25.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+4HR | 14.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+8HR | 5.880 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1, EOI+24HR | 1.007 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+5MIN | 50.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2, EOI+2HR | 25.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+2HR | 25.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+4HR | 14.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+8HR | 6.535 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3, EOI+24HR | 2.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+30MIN | 31.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+45MIN | 27.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+1HR | 25.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4, EOI+8HR | 3.125 ng/mL |
Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Pre-dose on W 1, 4, 7, 10, 13, 19, 37, 55, 73, 91; EOI+5min/ 4HR on W 1, 4, 7, 10, 13, 19, 37, 55, 91; EOI+15min/ 30min/ 45min/ 1HR/ 6HR on W 1, 4, 7; EOI+2HR on W 1, 4, 7, 10, 13, 19, 37, 55, 73; EOI+8HR/24 HR on W 1, 4, 7, 10, 13, 19, 91
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+5MIN | 19.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, EOI+5MIN | 22.700 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+5MIN | 24.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, EOI+2HR | 2.050 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+15MIN | 20.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+4HR | 0.870 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+30MIN | 16.050 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, EOI+4HR | 0.338 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+45MIN | 12.800 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+4HR | 5.870 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+1HR | 10.370 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK73, PREDOSE | 0.204 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+2HR | 3.905 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK73, EOI+2HR | 2.770 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+4HR | 1.064 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+6HR | 0.355 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91, EOI+5MIN | 19.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+8HR | 0.198 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91, EOI+4HR | 1.070 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91, EOI+8HR | 0.242 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+5MIN | 21.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+15MIN | 18.300 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+30MIN | 14.500 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+5MIN | 23.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+45MIN | 11.400 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+2HR | 2.860 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+1HR | 9.080 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+15MIN | 20.550 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+2HR | 4.130 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+4HR | 0.847 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+30MIN | 16.600 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+6HR | 0.225 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+5MIN | 20.350 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+8HR | 0.137 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+45MIN | 13.100 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+24HR | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, EOI+5MIN | 27.200 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+1HR | 10.355 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+5MIN | 22.900 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, EOI+2HR | 3.280 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+2HR | 4.270 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+2HR | 4.260 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+4HR | 1.080 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+8HR | 0.399 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+8HR | 0.094 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+4HR | 1.298 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, EOI+4HR | 0.605 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+6HR | 0.512 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+2HR | 4.205 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+8HR | 0.245 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, PREDOSE | 0.000 ng/mL |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+24HR | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+8HR | 2.040 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+5MIN | 51.350 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+2HR | 25.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+4HR | 12.190 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+8HR | 4.060 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, EOI+24HR | 1.227 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+5MIN | 85.950 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+2HR | 43.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+4HR | 23.600 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+8HR | 17.500 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19, EOI+24HR | 3.490 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, EOI+2HR | 20.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK37, EOI+4HR | 7.430 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, EOI+2HR | 17.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK55, EOI+4HR | 8.660 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+5MIN | 43.250 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+15MIN | 39.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+30MIN | 34.050 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+45MIN | 29.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+1HR | 26.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+2HR | 16.050 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+4HR | 6.055 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+6HR | 2.745 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+8HR | 1.160 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1, EOI+24HR | 0.302 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+5MIN | 42.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+15MIN | 40.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+30MIN | 34.700 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+45MIN | 31.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+1HR | 28.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+2HR | 16.650 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+4HR | 6.095 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+6HR | 2.360 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+8HR | 1.141 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4, EOI+24HR | 0.221 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+5MIN | 39.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+15MIN | 34.300 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+30MIN | 28.100 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+45MIN | 26.400 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+1HR | 22.900 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+2HR | 16.250 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+4HR | 6.820 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+6HR | 3.610 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7, EOI+24HR | 0.482 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, PREDOSE | 0.000 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+5MIN | 28.800 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+2HR | 15.550 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+4HR | 7.200 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+8HR | 3.135 ng/mL |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: GSK3745417 Concentrations in Plasma Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10, EOI+24HR | 1.015 ng/mL |
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 2, 5, 6, 8
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 2.2228 Hours | Geometric Coefficient of Variation 0.3535 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 2.9851 Hours | Geometric Coefficient of Variation 75.7387 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 2.1554 Hours | Geometric Coefficient of Variation 97.416 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK1 | 2.8013 Hours | Geometric Coefficient of Variation 71.6405 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 2.1751 Hours | Geometric Coefficient of Variation 65.5517 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK8 | 4.4423 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK2 | 22.0749 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK5 | 4.4441 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Imaging Q1W) | WEEK6 | 2.1489 Hours | — |
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1 to 5, 7, 10, 13, 19
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 3.8954 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 4.9496 Hours | Geometric Coefficient of Variation 25.3441 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 5.4788 Hours | Geometric Coefficient of Variation 163.2744 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 8.0669 Hours | Geometric Coefficient of Variation 323.3053 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 9.9205 Hours | Geometric Coefficient of Variation 148.2505 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 1.7032 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 1.8660 Hours | — |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 2.2804 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK10 | 2.5380 Hours | Geometric Coefficient of Variation 40.5521 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK4 | 3.7841 Hours | Geometric Coefficient of Variation 83.5863 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK5 | 2.5329 Hours | Geometric Coefficient of Variation 39.3756 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK19 | 6.7964 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK1 | 6.6082 Hours | Geometric Coefficient of Variation 97.7169 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK7 | 5.5454 Hours | Geometric Coefficient of Variation 43.6477 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK2 | 3.2754 Hours | Geometric Coefficient of Variation 147.9302 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK13 | 2.3912 Hours | Geometric Coefficient of Variation 21.7772 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q1W) | WEEK3 | 2.3642 Hours | Geometric Coefficient of Variation 72.3718 |
Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W)
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3745417 in combination with dostarlimab.
Time frame: Week 1, 4, 7, 10, 13, 19, 91
Population: Pharmacokinetic (PK) population. The number analyzed for each timepoint reflects the number of participants from the Overall PK population with a non-missing value at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 1.6491 Hours | Geometric Coefficient of Variation 105.7556 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 1.7825 Hours | Geometric Coefficient of Variation 64.9647 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 1.7101 Hours | Geometric Coefficient of Variation 121.4103 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 1.1499 Hours | Geometric Coefficient of Variation 54.3836 |
| Part 1A: GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK91 | 1.2513 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK7 | 10.1871 Hours | Geometric Coefficient of Variation 122.2331 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK19 | 6.5557 Hours | — |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK1 | 4.5289 Hours | Geometric Coefficient of Variation 65.1077 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK10 | 3.9067 Hours | Geometric Coefficient of Variation 59.4336 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK4 | 5.4869 Hours | Geometric Coefficient of Variation 96.3549 |
| Part 1A: Japan GSK3745417 0.1 mg (Q1W) | Part 2A: T1/2 Following Administration of GSK3745417 in Combination With Dostarlimab (Q3W) | WEEK13 | 5.6356 Hours | Geometric Coefficient of Variation 1.5314 |