Advanced Solid Tumors
Conditions
Keywords
Advanced solid tumors, UCB6114, Phase 1/2
Brief summary
The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114 administered as monotherapy or in combination with selected standard of care (SOC) regimens.
Interventions
DRUGginisortamab
Study participants will receive predefined doses of ginisortamab (UCB6114) administered intravenously at pre-specified time points.
DRUGtrifluridine/tipiracil
Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
DRUGmFOLFOX6
Study participants will receive predefined doses of oxaliplatin, Leucovorin and 5-fluorouracil as part of the mFOLFOX6 chemotherapy regimen administered as intravenous (iv) infusion at prespecified time points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Modular design, escalation & expansion modules. Depending on emerging data, not all modules may open
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be at least 18 years of age inclusive, at the time of signing the informed consent * Participant has advanced disease (ie, locally advanced or metastatic) * Participant has measurable or non-measurable disease as defined by the relevant Response Evaluation Criteria in Solid Tumors (RECIST) * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Part A specific: \- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, lung adenocarcinoma, lung squamous cell carcinoma, pancreatic adenocarcinoma, prostate adenocarcinoma, stomach adenocarcinoma, bladder urothelial carcinoma, or breast invasive carcinoma Part B and C specific: \- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction Part A1 specific: \- Participant has histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction, or pancreatic cancer
Exclusion criteria
* Participant has a known hypersensitivity to any components of the study medications or comparable drugs * Active and clinically significant bacterial, fungal, or viral infection, known infections with hepatitis B, hepatitis C, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness * Symptomatic central nervous system (CNS) malignancy or metastases. Screening of asymptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions prior to study enrolment * Current hematologic malignancies * Prior organ or allogeneic stem-cell transplantation * QT interval corrected (QTc) \>450 msec * Participant has impaired renal function * Alanine transaminase or AST are ≥2xULN (if liver metastases are present: ≥5xULN) * Participant has moderate or severe cardiovascular disease * Current or chronic history of liver disease or known hepatic or biliary abnormalities other than liver metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline until the End of Study (up to 3.8 years) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date on or after the first dose of UCB6114 up until the last dose of Ginisortamab (UCB6114) +30 days (i.e. up to 3.8 years). |
| Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | From Baseline until the End of Study (up to 3.8 years) | AE is any untoward medical occurrence in patient or clinical study participant, temporally associated with use of study medication, whether or not considered related to study medication. AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of study medication. TEAE: any AE with start date on or after first dose of UCB6114 up until last dose of Ginisortamab(UCB6114)+30 days. Event for which no Common Terminology Criteria for AE (CTCAE) severity grade was recorded by investigator but intensity was recorded instead was assigned as follows to CTCAE severity grade:Severe=Grade 3, Life Threatening (indicated on electronic case report form (eCRF) for event that is serious)=Grade 4, Death (indicated on the eCRF for event that is serious or has outcome of death)=Grade 5. As planned, data reported for National Cancer Institute (NCI) CTCAE grade \>=3 TEAEs and related TEAEs. |
| Number of Participants With Dose-limiting Toxicities (DLTs) | From Baseline throughout 28 days (Cycle 1) | DLT defined as any AE at least related to study medication that occurs during Cycle 1 and met following criteria: Grade (Gr) 3 or 4 nonhematological toxicity according to NCI CTCAE (Version 5.0) except for alopecia, or nausea, vomiting, or diarrhea that reverses to Gr ≤2 within 24 hours (hr) with appropriate medical therapy; Gr 3 or 4 biochemical abnormality that persists despite maximal supportive treatment or biochemical abnormalities that is symptomatic and nontransient; Any Gr ≥3 hematological toxicity of \>5 days duration or febrile neutropenia (absolute neutrophil count \[ANC\]\<1000/cubic millimeter\[mm3\] with single temperature of \>38.3°C or sustained temperature ≥38°C for more than one hr), infection with Gr 3 or 4 neutropenia, thrombocytopenia with bleeding or requiring platelet transfusion, or Gr 4 thrombocytopenia; Prolonged Gr 2 diarrhea (\>7 days) despite adequate antidiarrheal medication, or multiple Grade 1or 2 toxicities(eg, Gr 1 or 2 diarrhea, vomiting, rash, and fatigue). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Parts A: Cycle 1 (Day 1 end of infusion [EOI] and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose); Part A 1: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose) | Blood samples for ginisortamab serum concentration analysis were collected at different timepoints following the first dose of ginisortamab. The data is reported for Part A and A1. Pharmacokinetic Set (PKS). Lower Limit of Quantitation (LLOQ). |
| Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Part B and C: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose) | Blood samples for ginisortamab serum concentration analysis were collected at timepoints following (Cycle 1 Day 1) and the (Cycle 2 Day 1) administration of ginisortamab. Data is reported for Part B and Part C. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
The study started to enroll participants in July 2020 and concluded in April 2024.
Pre-assignment details
The Participant Flow refers to the Safety Set (SS).
Participants by arm
| Arm | Count |
|---|---|
| Part A: Ginisortamab 100 mg Participants received ginisortamab monotherapy 100 milligrams (mg) as an intravenously (iv) infusion every 2 weeks (Q2W) on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 3 |
| Part A: Ginisortamab 250 mg Participants received ginisortamab monotherapy 250 mg as an iv infusion Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 5 |
| Part A: Ginisortamab 500 mg Participants received ginisortamab monotherapy 500 mg as an iv infusion Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 5 |
| Part A: Ginisortamab 1000 mg Participants received ginisortamab monotherapy 1000 mg as an iv infusion Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 6 |
| Part A: Ginisortamab 2000 mg Participants received ginisortamab monotherapy 2000 mg as an iv infusion Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 6 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D Participants received ginisortamab monotherapy 2000 mg as an iv infusion (60-minute infusion) Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 8 |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D Participants received ginisortamab monotherapy 2000 mg as an iv infusion (30-minute infusion) Q2W on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 8 |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D Participants received ginisortamab monotherapy 3000 mg as an iv infusion (90-minute infusion) every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 8 |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D Participants received ginisortamab monotherapy 4000 mg as an iv infusion (120-minute infusion) every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 8 |
| Part B: Ginisortamab 500 mg + TFD/TPI SoC Participants received ginisortamab 500 mg as an iv infusion Q2W in combination with orally administered trifluridine/tipiracil (TFD/TPI) on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 9 |
| Part B: Ginisortamab 1000 mg + TFD/TPI SoC Participants received ginisortamab 1000 mg as an iv infusion Q2W in combination with orally administered TFD/TPI on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 4 |
| Part B: Ginisortamab 2000 mg + TFD/TPI SoC Participants received ginisortamab 2000 mg as an iv infusion Q2W in combination with orally administered TFD/TPI on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 8 |
| Part C: Ginisortamab 500 mg + mFOLFOX6 SoC Participants received ginisortamab 500 mg as an iv infusion Q2W in combination with mFOLFOX6 chemotherapy (oxaliplatin, leucovorin, and 5-fluorouracil) on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 5 |
| Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC Participants received ginisortamab 1000 mg as an iv infusion Q2W in combination with mFOLFOX6 chemotherapy (oxaliplatin, leucovorin, and 5-fluorouracil) on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 3 |
| Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC Participants received ginisortamab 2000 mg as an iv infusion Q2W in combination with mFOLFOX6 chemotherapy (oxaliplatin, leucovorin, and 5-fluorouracil) on Day 1 and Day 15 of each 28-day treatment cycle until the occurrence of progressive disease, unacceptable toxicity, or participant withdrawal. | 7 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Clinical Progression | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Clinical Progression in Combination with AE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Clinical Progression: Not suitable for SFU return | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Consent withdrawn by participant, not due to AE | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Disease Progression | 0 | 1 | 0 | 0 | 0 | 3 | 2 | 1 | 2 | 1 | 0 | 3 | 0 | 0 | 1 |
| Overall Study | Disease Progression Confirmed by Scans (CT/MRI) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Due to symptoms (New Brain Metastases) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Further Deterioration Noted at Clinic review | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Passed Away on The 30 Oct 2020 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Patient Deceased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Patient Discharged to Hospice | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Patient Passed Away | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progression | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Progressive Disease and Subsequent Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease - New Brain Mets on CT Head | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease (PD) | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Since no Treatment Administered at Cycle 2 Day 15 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Sponsor decision- sepsis (treatment delay) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Started a New Cancer Treatment | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Symptomatic Cancer - Unfit to take a call | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A: Ginisortamab 100 mg | Part A: Ginisortamab 250 mg | Part A: Ginisortamab 500 mg | Part A: Ginisortamab 1000 mg | Part A: Ginisortamab 2000 mg | Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Part B: Ginisortamab 500 mg + TFD/TPI SoC | Part B: Ginisortamab 1000 mg + TFD/TPI SoC | Part B: Ginisortamab 2000 mg + TFD/TPI SoC | Part C: Ginisortamab 500 mg + mFOLFOX6 SoC | Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC | Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.9 Years STANDARD_DEVIATION 10.7 | 65.0 Years STANDARD_DEVIATION 1 | 54.4 Years STANDARD_DEVIATION 11 | 58.2 Years STANDARD_DEVIATION 12.2 | 65.3 Years STANDARD_DEVIATION 8 | 60.7 Years STANDARD_DEVIATION 9.5 | 56.6 Years STANDARD_DEVIATION 12 | 67.3 Years STANDARD_DEVIATION 6.3 | 60.9 Years STANDARD_DEVIATION 6.7 | 60.8 Years STANDARD_DEVIATION 17.6 | 57.6 Years STANDARD_DEVIATION 9.5 | 51.5 Years STANDARD_DEVIATION 6.2 | 57.6 Years STANDARD_DEVIATION 14.2 | 58.6 Years STANDARD_DEVIATION 10.7 | 63.0 Years STANDARD_DEVIATION 13 | 61.1 Years STANDARD_DEVIATION 9.1 |
| Age, Customized 18 - <65 years | 61 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 7 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 4 Participants | 7 Participants | 3 Participants | 2 Participants | 5 Participants |
| Age, Customized 65 - <85 years | 32 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 5 Participants | 3 Participants | 4 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 93 Participants | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 4 Participants | 8 Participants | 5 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other/Mixed | 1 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 | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 82 Participants | 3 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 6 Participants | 3 Participants | 8 Participants | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 35 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 58 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 6 Participants | 5 Participants | 2 Participants | 6 Participants | 3 Participants | 2 Participants | 4 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 | 1 / 8 | 0 / 9 | 0 / 4 | 0 / 8 | 0 / 5 | 1 / 3 | 1 / 7 |
| other Total, other adverse events | 3 / 3 | 5 / 5 | 5 / 5 | 6 / 6 | 6 / 6 | 7 / 8 | 8 / 8 | 7 / 8 | 8 / 8 | 9 / 9 | 4 / 4 | 8 / 8 | 5 / 5 | 3 / 3 | 7 / 7 |
| serious Total, serious adverse events | 2 / 3 | 3 / 5 | 1 / 5 | 0 / 6 | 1 / 6 | 1 / 8 | 2 / 8 | 2 / 8 | 5 / 8 | 4 / 9 | 2 / 4 | 4 / 8 | 5 / 5 | 1 / 3 | 2 / 7 |
Outcome results
Primary
Number of Participants With Dose-limiting Toxicities (DLTs)
DLT defined as any AE at least related to study medication that occurs during Cycle 1 and met following criteria: Grade (Gr) 3 or 4 nonhematological toxicity according to NCI CTCAE (Version 5.0) except for alopecia, or nausea, vomiting, or diarrhea that reverses to Gr ≤2 within 24 hours (hr) with appropriate medical therapy; Gr 3 or 4 biochemical abnormality that persists despite maximal supportive treatment or biochemical abnormalities that is symptomatic and nontransient; Any Gr ≥3 hematological toxicity of \>5 days duration or febrile neutropenia (absolute neutrophil count \[ANC\]\<1000/cubic millimeter\[mm3\] with single temperature of \>38.3°C or sustained temperature ≥38°C for more than one hr), infection with Gr 3 or 4 neutropenia, thrombocytopenia with bleeding or requiring platelet transfusion, or Gr 4 thrombocytopenia; Prolonged Gr 2 diarrhea (\>7 days) despite adequate antidiarrheal medication, or multiple Grade 1or 2 toxicities(eg, Gr 1 or 2 diarrhea, vomiting, rash, and fatigue).
Time frame: From Baseline throughout 28 days (Cycle 1)
Population: The SS consisted of all study participants who received at least 1 full or partial dose of Ginisortamab (UCB6114).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Ginisortamab 100 mg | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A: Ginisortamab 250 mg | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A: Ginisortamab 500 mg | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A: Ginisortamab 1000 mg | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A: Ginisortamab 2000 mg | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part B: Ginisortamab 500 mg + TFD/TPI SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 1 Participants |
| Part B: Ginisortamab 1000 mg + TFD/TPI SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part B: Ginisortamab 2000 mg + TFD/TPI SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 1 Participants |
| Part C: Ginisortamab 500 mg + mFOLFOX6 SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC | Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
Primary
Percentage of Participants Based on Severity of Treatment-emergent Adverse Events
AE is any untoward medical occurrence in patient or clinical study participant, temporally associated with use of study medication, whether or not considered related to study medication. AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of study medication. TEAE: any AE with start date on or after first dose of UCB6114 up until last dose of Ginisortamab(UCB6114)+30 days. Event for which no Common Terminology Criteria for AE (CTCAE) severity grade was recorded by investigator but intensity was recorded instead was assigned as follows to CTCAE severity grade:Severe=Grade 3, Life Threatening (indicated on electronic case report form (eCRF) for event that is serious)=Grade 4, Death (indicated on the eCRF for event that is serious or has outcome of death)=Grade 5. As planned, data reported for National Cancer Institute (NCI) CTCAE grade \>=3 TEAEs and related TEAEs.
Time frame: From Baseline until the End of Study (up to 3.8 years)
Population: The SS consisted of all study participants who received at least 1 full or partial dose of Ginisortamab (UCB6114).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Ginisortamab 100 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 66.7 percentage of participants |
| Part A: Ginisortamab 100 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A: Ginisortamab 250 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A: Ginisortamab 250 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 40.0 percentage of participants |
| Part A: Ginisortamab 500 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 40.0 percentage of participants |
| Part A: Ginisortamab 500 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A: Ginisortamab 1000 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A: Ginisortamab 1000 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 0 percentage of participants |
| Part A: Ginisortamab 2000 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 50.0 percentage of participants |
| Part A: Ginisortamab 2000 mg | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 62.5 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 50.0 percentage of participants |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 37.5 percentage of participants |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 62.5 percentage of participants |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 12.5 percentage of participants |
| Part B: Ginisortamab 500 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 22.2 percentage of participants |
| Part B: Ginisortamab 500 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 55.6 percentage of participants |
| Part B: Ginisortamab 1000 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part B: Ginisortamab 1000 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 75.0 percentage of participants |
| Part B: Ginisortamab 2000 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 25.0 percentage of participants |
| Part B: Ginisortamab 2000 mg + TFD/TPI SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 87.5 percentage of participants |
| Part C: Ginisortamab 500 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 100 percentage of participants |
| Part C: Ginisortamab 500 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 40.0 percentage of participants |
| Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 100 percentage of participants |
| Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 0 percentage of participants |
| Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 related TEAEs | 14.3 percentage of participants |
| Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC | Percentage of Participants Based on Severity of Treatment-emergent Adverse Events | NCI CTCAE grade >=3 TEAEs | 85.7 percentage of participants |
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date on or after the first dose of UCB6114 up until the last dose of Ginisortamab (UCB6114) +30 days (i.e. up to 3.8 years).
Time frame: From Baseline until the End of Study (up to 3.8 years)
Population: The SS consisted of all study participants who received at least 1 full or partial dose of Ginisortamab (UCB6114).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Ginisortamab 100 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A: Ginisortamab 250 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A: Ginisortamab 500 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A: Ginisortamab 1000 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A: Ginisortamab 2000 mg | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 87.5 percentage of participants |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 87.5 percentage of participants |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part B: Ginisortamab 500 mg + TFD/TPI SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part B: Ginisortamab 1000 mg + TFD/TPI SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part B: Ginisortamab 2000 mg + TFD/TPI SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part C: Ginisortamab 500 mg + mFOLFOX6 SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part C: Ginisortamab 1000 mg + mFOLFOX6 SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Part C: Ginisortamab 2000 mg + mFOLFOX6 SoC | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
Secondary
Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort
Blood samples for ginisortamab serum concentration analysis were collected at different timepoints following the first dose of ginisortamab. The data is reported for Part A and A1. Pharmacokinetic Set (PKS). Lower Limit of Quantitation (LLOQ).
Time frame: Parts A: Cycle 1 (Day 1 end of infusion [EOI] and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose); Part A 1: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose)
Population: PKS:all participants of SS with \>=1 evaluable PKS concentration (ie, sample above LLOQ\[0.02μg/mL\] and for which date, sample time, prior date dosing time are known). Number analyzed:participants evaluable at specified time points. Dosing was only performed on Day 1 of each cycle for Part A1:Ginisortamab 3000mg Q3W(90-min) 21-day and Ginisortamab 4000mg Q4W(120-min) 28-day arms. Hence, Predose, Day 15 of Cycle 1 was not collected. No arms of Part A1 had data collection on Cycle 2 Day 15 Predose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Ginisortamab 100 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 15 Predose | NA microgram per milliliter (ug/mL) | — |
| Part A: Ginisortamab 100 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 18.0477 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 10.0206 |
| Part A: Ginisortamab 100 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | NA microgram per milliliter (ug/mL) | — |
| Part A: Ginisortamab 100 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 4.4210 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 10.1288 |
| Part A: Ginisortamab 250 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 15 Predose | NA microgram per milliliter (ug/mL) | — |
| Part A: Ginisortamab 250 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | NA microgram per milliliter (ug/mL) | — |
| Part A: Ginisortamab 250 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 72.5261 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 24.1924 |
| Part A: Ginisortamab 250 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 12.8115 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 27.1385 |
| Part A: Ginisortamab 500 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 24.3743 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 31.2011 |
| Part A: Ginisortamab 500 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 130.7757 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 14.1088 |
| Part A: Ginisortamab 500 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 34.6409 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 26.9986 |
| Part A: Ginisortamab 500 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 15 Predose | 42.6861 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 38.1929 |
| Part A: Ginisortamab 1000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 61.4527 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 33.1491 |
| Part A: Ginisortamab 1000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 277.5536 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 10.8287 |
| Part A: Ginisortamab 1000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 67.0799 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 37.9557 |
| Part A: Ginisortamab 1000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 15 Predose | 78.2336 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 35.0467 |
| Part A: Ginisortamab 2000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 15 Predose | 166.4011 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 34.1041 |
| Part A: Ginisortamab 2000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 552.3530 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 19.5548 |
| Part A: Ginisortamab 2000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 92.0396 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 38.4595 |
| Part A: Ginisortamab 2000 mg | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 149.3886 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 37.0769 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 592.2331 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 26.1556 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 193.4242 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 34.5942 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 105.5277 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 25.1756 |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 593.1846 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 22.2154 |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 147.2154 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 26.4979 |
| Part A1: Ginisortamab 2000 mg Q2W (30-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 15 Predose | 97.1957 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 39.3439 |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 124.7274 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 44.3198 |
| Part A1: Ginisortamab 3000 mg Q3W (90-min), 21D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 946.0883 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 19.3798 |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 1 Day 1 EOI | 1357.6103 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 20.4135 |
| Part A1: Ginisortamab 4000 mg Q4W (120-min), 28D | Part A and A1: UCB6114 Serum Concentration by Scheduled Assessment and Cohort | Cycle 2 Day 1 Predose | 98.9331 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 33.8567 |
Secondary
Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level
Blood samples for ginisortamab serum concentration analysis were collected at timepoints following (Cycle 1 Day 1) and the (Cycle 2 Day 1) administration of ginisortamab. Data is reported for Part B and Part C.
Time frame: Part B and C: Cycle 1 (Day 1 EOI and Day 15 Predose), Cycle 2 (Day 1 Predose and Day 15 Predose)
Population: The PKS included all study participants in the SS (all study participants who received at least 1 full or partial dose of Ginisortamab \[UCB6114\]) who had at least 1 evaluable PKS concentration (ie, a sample which is above the lower limit of quantitation \[0.02μg/mL\] and for which the date and time of the sample and prior date and time of dosing are known). Here, number analyzed signifies participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Ginisortamab 100 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 104.0606 ug/mL | Geometric Coefficient of Variation 15.3565 |
| Part A: Ginisortamab 100 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 19.7473 ug/mL | Geometric Coefficient of Variation 42.6072 |
| Part A: Ginisortamab 100 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 33.0061 ug/mL | Geometric Coefficient of Variation 35.3957 |
| Part A: Ginisortamab 100 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | 38.3595 ug/mL | Geometric Coefficient of Variation 42.1013 |
| Part A: Ginisortamab 250 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 61.0398 ug/mL | Geometric Coefficient of Variation 5.0117 |
| Part A: Ginisortamab 250 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 37.4171 ug/mL | Geometric Coefficient of Variation 14.8496 |
| Part A: Ginisortamab 250 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 250.8708 ug/mL | Geometric Coefficient of Variation 7.6032 |
| Part A: Ginisortamab 250 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | 55.0249 ug/mL | Geometric Coefficient of Variation 39.4082 |
| Part A: Ginisortamab 500 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | 135.5849 ug/mL | Geometric Coefficient of Variation 32.8644 |
| Part A: Ginisortamab 500 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 118.0926 ug/mL | Geometric Coefficient of Variation 29.3051 |
| Part A: Ginisortamab 500 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 83.4236 ug/mL | Geometric Coefficient of Variation 30.8533 |
| Part A: Ginisortamab 500 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 463.5265 ug/mL | Geometric Coefficient of Variation 28.6333 |
| Part A: Ginisortamab 1000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 122.8221 ug/mL | Geometric Coefficient of Variation 14.8778 |
| Part A: Ginisortamab 1000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | 24.7120 ug/mL | Geometric Coefficient of Variation 83.6183 |
| Part A: Ginisortamab 1000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 16.8917 ug/mL | Geometric Coefficient of Variation 33.2664 |
| Part A: Ginisortamab 1000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 25.4863 ug/mL | Geometric Coefficient of Variation 53.6347 |
| Part A: Ginisortamab 2000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 82.7657 ug/mL | Geometric Coefficient of Variation 47.9648 |
| Part A: Ginisortamab 2000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | NA ug/mL | — |
| Part A: Ginisortamab 2000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 32.3094 ug/mL | Geometric Coefficient of Variation 56.2327 |
| Part A: Ginisortamab 2000 mg | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 175.0745 ug/mL | Geometric Coefficient of Variation 34.739 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 15 Predose | 70.7026 ug/mL | Geometric Coefficient of Variation 50.9842 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 1 Predose | 141.6084 ug/mL | Geometric Coefficient of Variation 30.831 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 2 Day 15 Predose | 135.0042 ug/mL | Geometric Coefficient of Variation 43.8716 |
| Part A1: Ginisortamab 2000 mg Q2W (60-min), 28D | Part B and C: UCB6114 Concentration by Scheduled Assessment and Dose Level | Cycle 1 Day 1 EOI | 471.9576 ug/mL | Geometric Coefficient of Variation 17.1727 |