Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer, Hepatocellular Cancer, Bladder Cancer, Sarcoma, Head and Neck Cancer, Colorectal Cancer, Ovarian Cancer, Squamous Cell Carcinoma
Conditions
Keywords
Advanced malignancies
Brief summary
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 \[PD-1\] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them. The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.
Interventions
BIOLOGICALPF-07263689
Genetically engineered oncolytic vaccinia virus
BIOLOGICALSasanlimab
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents * Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 \[PDL1\] if applicable) or for whom no standard therapy is available for their tumor type * Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020) * Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only) * Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy * Eastern Cooperative Oncology Group (ECOG) PS 0-1 * Adequate hematologic, renal, and liver functions * Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria. * Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2)
Exclusion criteria
* Other active malignancy * Recent major surgery * Systemic anticancer therapy and chemotherapy within protocol-defined washout period * Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years * Current or history of myocarditis or congestive heart failure (New York Heart Association \[NYHA\] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction * Active or history of interstitial lung disease (ILD)/pneumonitis * Patients requiring chronic systemic immunosuppressants * History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy * Known symptomatic brain metastases requiring steroids * History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment * Any prior or planned organ transplant * Presence of any open, active wound requiring treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 days | DLTs=occurrence of any of following adverse events (AEs) attributable to PF-07263689 in first cycle (cycle=28 days): Hematologic: grade(G)4 neutropenia lasting \>5 days; febrile neutropenia; G3 neutropenia with infection, thrombocytopenia with bleeding; G4 thrombocytopenia. Non-hematologic: any treatment-related G\>=3 toxicity; clinical events consistent with Hy's law; any G3 cytokine release syndrome (CRS) not improving to G\<=2 within 72 hours despite medical management; any G4 CRC; G\>=3 toxicity of any duration affecting vital organs; G4 vaccinia infection lasting \>=6 days; G\>=3 toxicities persisting for \>3 days despite medical therapy (e.g. nausea, vomiting, diarrhea, fatigue); G \>=3 rash not resolving to G\<2 within 21 days with supportive measures; G\>=3 lab abnormalities not controlled to G \<=2 with or without appropriate medical management within 3 days; treatment-related AE inducing a delay by 2 weeks in receiving next scheduled dose; clinically important or persistent toxicities. |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that at any dose met 1 or more of the following criteria: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; an important medical event; required inpatient hospitalization or prolongation of existing hospitalization. TEAE was defined as any adverse event that occurred during the on-treatment period, on or after the first dose of study treatment. Relatedness was based on investigator's assessment. |
| Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE was defined as any AE that occurred during the on-treatment period, on or after the first dose of study treatment. AEs were graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE. |
| Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure) | Hematology abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported. |
| Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure) | Clinical chemistry abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported. |
| Part 2: Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events, Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that at any dose met 1 or more of the following criteria: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; an important medical event; required inpatient hospitalization or prolongation of existing hospitalization. TEAE was defined as any adverse event that occurred during the on-treatment period, on or after the first dose of study treatment. Relatedness was planned to be assessed by investigator. |
| Part 2: Number of Participants With Treatment Emergent Adverse Events Based on Maximum CTCAE Version 5 Grade | From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years) | AEs were planned to be graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE. |
| Part 2: Number of Participants With Laboratory Abnormalities by Maximum On-Treatment CTCAE Grade | From first dose of study treatment until 35 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years) | Hematology and clinical chemistry parameters were planned to be assessed. |
| Part 2: Objective Response Rate | From first dose of study treatment until CR or PR (up to 2 years) | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) and was determined using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab | From Baseline (pre-dose) on Day 1 up to Day 22 | A participant was considered NAb positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive neutralizing antibodies against PF-07263689 is presented in this outcome measure. Data was not collected for sasanlimab as no participants were enrolled in Part 1b of the study. |
| Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies | From Baseline (pre-dose) on Day 1 up to Day 22 | A participant was considered anti-drug antibody (ADA) positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive anti-interleukin 2 antibodies against PF-07263689 is presented in this outcome measure. |
| Part 2: Maximum Observed Concentration (Cmax) of PF-7263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 2: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 2: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 2: Trough Concentration of Sasanlimab | Pre-dose on Day 1, 8, 15 and 22 | — |
| Part 2: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | 30, 45 and 60 days after the last PF-07263689 dose | — |
| Part 2: Percentage of Participants With Positive Anti-drug Antibodies Against PF-07263689 and Sasanlimab | From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years) | — |
| Part 1: Objective Response Rate | From first dose of study treatment until CR or PR (up to maximum follow-up of 10.45 months) | ORR was defined as the percentage of participants with a best overall response of CR or PR and was determined using RECIST version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. 95% confidence interval (CI) was based on Clopper-Pearson method. |
| Part 2: Percentage of Participants With Positive Anti-interleukin 2 Antibodies | From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years) | — |
| Part 2: Titer for Anti-IL2 Antibodies | From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years) | — |
| Part 2: Disease Control Rate | From start of study treatment until CR, PR or SD (up to 2 years) | Disease control rate was the percentage of participants with CR, PR or stable disease (SD), as defined by RECIST 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. SD: Does not qualify for CR, PR, or progression. All target lesions assessed. |
| Part 2: Duration of Response | From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to 2 years) | Duration of response was defined as the time from first documentation of CR or PR to date of first documentation of progressive disease (PD) or death due to any cause. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non- pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. |
| Part 2: Progression Free Survival | From start date of treatment to the date of first documentation of PD or death due to any cause (up to 2 years) | Progression free survival was defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. |
| Part 2: Time to Progression | From start date of treatment to the date of first documentation of PD (up to 2 years) | Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. |
| Part 2: Overall Survival | From start of study treatment to the date of death from any cause (up to 2 years) | Overall survival was defined as the duration from the start of study treatment to the date of death from any cause. |
| Part 2: Titer for Anti-PF-07263689 Antibody | From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years) | — |
| Part 1: Duration of Response | From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months) | Duration of response was defined as the time from first documentation of CR or PR to date of first documentation of progressive disease (PD) or death due to any cause. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non- pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. |
| Part 1: Progression Free Survival | From start date of treatment to the date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months) | Progression free survival was defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method. |
| Part 1: Time to Progression | From start date of treatment to the date of first documentation of PD (up to maximum follow-up of 10.45 months) | Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method. |
| Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood | Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose) | — |
| Part 1b: Trough Concentration of Sasanlimab | pre-dose on Day 1, 8, 15 and 22 | — |
| Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | At 30, 45 and 60 days post last dose of study treatment (up to 24 days of treatment exposure) | Viral titers in each matrix (saliva, urine and skin swabs \[30 days post last dose only\]) at 30, 45 and 60 days after last dose of study treatment is reported in this outcome measure. |
Countries
United States
Participant flow
Recruitment details
Study was planned to be conducted in 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and combination with sasanlimab (Part 1B) and Part 2 dose expansion for the combination therapy. The study was terminated during Part 1A due to sponsor's business decision; hence, Part 1B and Part 2 were not conducted and no participants were enrolled in Part 1B and 2.
Pre-assignment details
A total of 13 participants were enrolled in Part 1A of the study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1A PF-07263689 2*10^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 2\*10\^8 plaque forming unit (PFU) once weekly for 4 weeks as an intravenous (IV) push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study. | 3 |
| Part 1A PF-07263689 6*10^8 PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 6\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study. | 4 |
| Part 1A PF-07263689 20*10^8PFU Participants with any advanced or metastatic solid tumor indications with approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents were administered PF-07263689 at a dose 20\*10\^8 PFU once weekly for 4 weeks as an IV push. Participants were followed up for up to 90 days post-last dose of study treatment. Participants were followed up for survival until death, withdrawal of consent, or end of the study. | 6 |
| Part 1B: PF-07263689 + Sasanlimab Participants were planned to receive escalating doses of PF-07263689 in combination with sasanlimab. | 0 |
| Part 2: PF-07263689 + Sasanlimab Participants were planned to receive PF-07263689 in combination with sasanlimab at the preliminary combination recommended Phase 2 dose from Part 1B. | 0 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Follow up | Other | 2 | 0 | 2 | 0 | 0 |
| Follow up | Study terminated by sponsor | 0 | 0 | 2 | 0 | 0 |
| Long-term Follow-up | Death | 0 | 1 | 0 | 0 | 0 |
| Long-term Follow-up | Study terminated by sponsor | 2 | 2 | 2 | 0 | 0 |
| Treatment Phase | Adverse Event | 0 | 0 | 2 | 0 | 0 |
| Treatment Phase | Global deterioration of health status | 0 | 1 | 0 | 0 | 0 |
| Treatment Phase | Progressive disease | 0 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1A PF-07263689 20*10^8PFU | Total | Part 1A PF-07263689 2*10^8 PFU | Part 1A PF-07263689 6*10^8 PFU | Part 2: PF-07263689 + Sasanlimab | Part 1B: PF-07263689 + Sasanlimab |
|---|---|---|---|---|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 9.4 | 53.6 Years STANDARD_DEVIATION 9.74 | 56.3 Years STANDARD_DEVIATION 6.43 | 61.0 Years STANDARD_DEVIATION 6.78 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 2 Participants | 3 Participants | 0 Participants | 0 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 4 | 0 / 6 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 3 / 3 | 4 / 4 | 6 / 6 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 1 / 4 | 2 / 6 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade
Clinical chemistry abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.
Time frame: From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)
Population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 0 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 1 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 3 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypercalcemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypernatremia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin I Increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypermagnesemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 2 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 3 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 2 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 0 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin I Increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypercalcemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypernatremia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 2 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 1 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin T Increased: Grade 0 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin T Increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypermagnesemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 1 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 3 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 0 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 3 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 2 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 1 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 2 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypokalemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 2 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 3 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypermagnesemia: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 2 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypernatremia: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 0 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyperkalemia: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 3 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoalbuminemia: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypercalcemia: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alanine aminotransferase increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Aspartate aminotransferase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Alkaline phosphatase increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypocalcemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin T Increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypomagnesemia: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine phosphokinase increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin I Increased: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hyponatremia: Grade 0 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Cardiac Troponin T Increased: Grade 0 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Hypoglycemia: Grade 0 | 3 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Blood bilirubin increased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Clinical Chemistry Abnormalities by Maximum On-Treatment CTCAE Grade | Creatinine increased: Grade 0 | 4 Participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs=occurrence of any of following adverse events (AEs) attributable to PF-07263689 in first cycle (cycle=28 days): Hematologic: grade(G)4 neutropenia lasting \>5 days; febrile neutropenia; G3 neutropenia with infection, thrombocytopenia with bleeding; G4 thrombocytopenia. Non-hematologic: any treatment-related G\>=3 toxicity; clinical events consistent with Hy's law; any G3 cytokine release syndrome (CRS) not improving to G\<=2 within 72 hours despite medical management; any G4 CRC; G\>=3 toxicity of any duration affecting vital organs; G4 vaccinia infection lasting \>=6 days; G\>=3 toxicities persisting for \>3 days despite medical therapy (e.g. nausea, vomiting, diarrhea, fatigue); G \>=3 rash not resolving to G\<2 within 21 days with supportive measures; G\>=3 lab abnormalities not controlled to G \<=2 with or without appropriate medical management within 3 days; treatment-related AE inducing a delay by 2 weeks in receiving next scheduled dose; clinically important or persistent toxicities.
Time frame: Up to 28 days
Population: DLT evaluable set included participants who received 3 of the 4 doses of PF-07263689 and had completed the scheduled safety assessments during the DLT observation period or had experienced a DLT. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade
Hematology abnormalities were graded using CTCAE version 5 where, grade 0=non-missing lab value outside the grading range for the corresponding lab parameter; grade 1=mild; grade 2=moderate; grade 3=severe; grade 4= life-threatening. Only those categories with non-zero values for any of the arms have been reported.
Time frame: From first dose of study treatment until 1 month follow-up (28+/-7) days after last dose of study treatment (up to 24 days of treatment exposure)
Population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 3 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Hemoglobin increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 3 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 0 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 0 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 0 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 0 | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 2 | 1 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Leukocytosis: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 0 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 2 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 0 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 3 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Hemoglobin increased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Leukocytosis: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 0 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 2 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 3 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 0 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 2 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 0 | 3 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 2 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count increased: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 1 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 0 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 1 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Neutrophil count decreased: Grade 2 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 2 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 2 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 0 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 1 | 3 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | White blood cell decreased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Leukocytosis: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Platelet count decreased: Grade 1 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 0 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Activated PTT prolonged: Grade 0 | 3 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 2 | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Hemoglobin increased: Grade 0 | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | INR increased: Grade 0 | 5 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Lymphocyte count decreased: Grade 3 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Hematology Abnormalities by Maximum On-Treatment CTCAE Grade | Anemia: Grade 3 | 1 Participants |
Primary
Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE was defined as any AE that occurred during the on-treatment period, on or after the first dose of study treatment. AEs were graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.
Time frame: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months)
Population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 4 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 3 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 1 | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 2 | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 5 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 3 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 1 | 2 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 2 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 4 | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 5 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 5 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 4 | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 1 | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 3 | 4 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events Based on Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade | Grade 2 | 1 Participants |
Primary
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that at any dose met 1 or more of the following criteria: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; an important medical event; required inpatient hospitalization or prolongation of existing hospitalization. TEAE was defined as any adverse event that occurred during the on-treatment period, on or after the first dose of study treatment. Relatedness was based on investigator's assessment.
Time frame: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to maximum of 10.45 months)
Population: Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | TEAEs | 3 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | SAEs | 0 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related TEAEs | 2 Participants |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related SAEs | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related SAEs | 0 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | TEAEs | 4 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related TEAEs | 3 Participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | SAEs | 1 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related SAEs | 0 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | SAEs | 2 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | Treatment related TEAEs | 6 Participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events | TEAEs | 6 Participants |
Primary
Part 2: Number of Participants With Laboratory Abnormalities by Maximum On-Treatment CTCAE Grade
Hematology and clinical chemistry parameters were planned to be assessed.
Time frame: From first dose of study treatment until 35 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Primary
Part 2: Number of Participants With Treatment Emergent Adverse Events Based on Maximum CTCAE Version 5 Grade
AEs were planned to be graded using CTCAE version 5 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.
Time frame: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Primary
Part 2: Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events, Treatment Related Treatment Emergent Adverse Events and Treatment Related Serious Adverse Events
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that at any dose met 1 or more of the following criteria: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; an important medical event; required inpatient hospitalization or prolongation of existing hospitalization. TEAE was defined as any adverse event that occurred during the on-treatment period, on or after the first dose of study treatment. Relatedness was planned to be assessed by investigator.
Time frame: From first dose of study treatment until 90 days after last dose of study treatment or before start of new anti-cancer therapy (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Primary
Part 2: Objective Response Rate
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) and was determined using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
Time frame: From first dose of study treatment until CR or PR (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood | NA Hours*copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood | NA Hours*copies per milliliter |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood | NA Hours*copies per milliliter |
Secondary
Part 1b: Trough Concentration of Sasanlimab
Time frame: pre-dose on Day 1, 8, 15 and 22
Population: Data was not collected as no participants were enrolled in Part 1b of the study due to study termination.
Secondary
Part 1: Duration of Response
Duration of response was defined as the time from first documentation of CR or PR to date of first documentation of progressive disease (PD) or death due to any cause. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non- pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions.
Time frame: From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months)
Population: Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. Only participants with CR or PR were analyzed. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
Secondary
Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood | NA Copies per milliliter |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Maximum Observed Concentration (Cmax) of PF-07263689 in Blood | NA Copies per milliliter |
Secondary
Part 1: Objective Response Rate
ORR was defined as the percentage of participants with a best overall response of CR or PR and was determined using RECIST version 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. 95% confidence interval (CI) was based on Clopper-Pearson method.
Time frame: From first dose of study treatment until CR or PR (up to maximum follow-up of 10.45 months)
Population: Response evaluable set included all participants who received at least one dose of study treatment and had baseline disease assessment \[or measurable disease at baseline, if applicable\] and at least one post-baseline disease assessment. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Objective Response Rate | 0 Percentage of participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Objective Response Rate | 0 Percentage of participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Objective Response Rate | 0 Percentage of participants |
Secondary
Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies
A participant was considered anti-drug antibody (ADA) positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive anti-interleukin 2 antibodies against PF-07263689 is presented in this outcome measure.
Time frame: From Baseline (pre-dose) on Day 1 up to Day 22
Population: Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies | 0.0 Percentage of participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies | 25.0 Percentage of participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Percentage of Participants With Positive Anti-interleukin 2 Antibodies | 0.0 Percentage of participants |
Secondary
Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab
A participant was considered NAb positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced) or (2) positive titer at baseline and had a ratio of \>= 4 in titer (dilution) to baseline in \>= 1 post-treatment sample (treatment-boosted). Percentage of participants with positive neutralizing antibodies against PF-07263689 is presented in this outcome measure. Data was not collected for sasanlimab as no participants were enrolled in Part 1b of the study.
Time frame: From Baseline (pre-dose) on Day 1 up to Day 22
Population: Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab | 66.7 Percentage of participants |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab | 50.0 Percentage of participants |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Percentage of Participants With Positive Neutralizing Antibodies Against PF-07263689 and Sasanlimab | 100.0 Percentage of participants |
Secondary
Part 1: Progression Free Survival
Progression free survival was defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.
Time frame: From start date of treatment to the date of first documentation of PD or death due to any cause (up to maximum follow-up of 10.45 months)
Population: Full analysis set included all enrolled participants. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Progression Free Survival | 1.4 Months |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Progression Free Survival | 1.5 Months |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Progression Free Survival | 1.4 Months |
Secondary
Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Blood viral load Kinetics Analysis Set included all enrolled participants treated who did not have protocol deviations influencing viral load kinetics assessment, and had sufficient information to estimate at least 1 of the parameters of interest. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood | NA Hours |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood | NA Hours |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood | NA Hours |
Secondary
Part 1: Time to Progression
Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions. 95% CI was based on Brookmeyer and Crowley method.
Time frame: From start date of treatment to the date of first documentation of PD (up to maximum follow-up of 10.45 months)
Population: Full analysis set included all enrolled participants. Data is not reported for Part 1b as no participants were enrolled and data was not collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Time to Progression | 1.4 Months |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Time to Progression | 1.5 Months |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Time to Progression | 1.4 Months |
Secondary
Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose
Viral titers in each matrix (saliva, urine and skin swabs \[30 days post last dose only\]) at 30, 45 and 60 days after last dose of study treatment is reported in this outcome measure.
Time frame: At 30, 45 and 60 days post last dose of study treatment (up to 24 days of treatment exposure)
Population: Vector Shedding Analysis Set included all enrolled participants who were treated and had at least 1 analyte concentration above the lower limit of quantitation. Data is not reported for Part 1b as no participants were enrolled and data was not collected. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and contributed data to the table and 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Skin swab; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 60 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 45 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 45 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 2*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 60 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 45 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 60 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Skin swab; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 30 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 60 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 6*10^8 PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 45 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Saliva; 45 days post last dose | NA Copies per milliliter |
| Part 1A PF-07263689 20*10^8PFU | Part 1: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose | Urine; 45 days post last dose | NA Copies per milliliter |
Secondary
Part 2: Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration of PF-07263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Disease Control Rate
Disease control rate was the percentage of participants with CR, PR or stable disease (SD), as defined by RECIST 1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. SD: Does not qualify for CR, PR, or progression. All target lesions assessed.
Time frame: From start of study treatment until CR, PR or SD (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Duration of Response
Duration of response was defined as the time from first documentation of CR or PR to date of first documentation of progressive disease (PD) or death due to any cause. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non- pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions.
Time frame: From first documentation of CR or PR to date of first documentation of PD or death due to any cause (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Maximum Observed Concentration (Cmax) of PF-7263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Overall Survival
Overall survival was defined as the duration from the start of study treatment to the date of death from any cause.
Time frame: From start of study treatment to the date of death from any cause (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Percentage of Participants With Positive Anti-drug Antibodies Against PF-07263689 and Sasanlimab
Time frame: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Percentage of Participants With Positive Anti-interleukin 2 Antibodies
Time frame: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Progression Free Survival
Progression free survival was defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions.
Time frame: From start date of treatment to the date of first documentation of PD or death due to any cause (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Time to Maximum Concentration (Tmax) of PF-07263689 in Blood
Time frame: Day 1 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 2, Day 3, Day 4, Day 8 (pre-dose, 0.5, 1, 4, 8 hours post-dose), Day 9, Day 10, Day 15 and 22 (pre-dose and 4 hours post-dose)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Time to Progression
Time to progression was defined as the time from start date of treatment to the date of the first documentation of PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm and unequivocal progression of pre-existing lesions.
Time frame: From start date of treatment to the date of first documentation of PD (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Titer for Anti-IL2 Antibodies
Time frame: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Titer for Anti-PF-07263689 Antibody
Time frame: From first dose of study treatment until 60 days after last dose of study treatment (up to 2 years)
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Trough Concentration of Sasanlimab
Time frame: Pre-dose on Day 1, 8, 15 and 22
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.
Secondary
Part 2: Viral Titers in Saliva, Urine and Skin Swabs During 30, 45 and 60 Days After the Last PF-07263689 Dose
Time frame: 30, 45 and 60 days after the last PF-07263689 dose
Population: Data was not collected as no participants were enrolled in Part 2 of the study due to study termination.