Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
Conditions
Keywords
Gastric cancer, Esophageal cancer, Colorectal cancer, Advanced esophageal cancer, Metastatic esophageal cancer, Advanced colorectal cancer, Metastatic gastric cancer, Advanced gastric cancer, Metastatic colorectal cancer, GUCY2c, Anti-PD1, Anti-VEGF, Measurable disease, PF-07062119, PF-06801591, Bevacizumab
Brief summary
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
Detailed description
This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-PD-1) and in combination with an anti-vascular endothelial growth factor (anti-VEGF). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-PD-1 and in combination with anti-VEGF (Part 1B) followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD 1 and in combination with anti-VEGF (Part 2).
Interventions
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit. * For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1) * Measurable disease as defined by RECIST 1.1 is required (Part 2)
Exclusion criteria
* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 3 weeks prior to study entry * Last anti-cancer treatment within 4 weeks prior to study entry * Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication * Active or history of clinically significant gastrointestinal disease * Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry * Pregnant or breastfeeding female patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 28 Days | Hematological DLTs: * Grade 3 neutropenia lasting \>5 days * Febrile neutropenia defined as an ANC \<1.0 x 10 ̂9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour * Grade ≥3 Neutropenia with infection * Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding * any Grade 4 Thrombocytopenia * Anemia or Thrombocytopenia requiring transfusion Non Hematological DLTs: * Grade ≥3 fatigue lasting ≥7 days * for participants with liver, bone, or lung metastasis, an AST or ALT increase \>8 x ULN or ALP \>10 x ULN; * confirmed DILI meeting Hy's law criteria * Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care * Grade 4 Vomiting or Diarrhea * Grade ≥3 CRS regardless of duration * Grade ≥3 QTcF prolongation irrespective of duration * any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor. |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | 4 Years | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. |
| Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | 4 Years | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5. |
| Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | 4 Years | The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied. |
| Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | 4 Years | The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 and Cycle 4 Day 1 | AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1 | AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 and Cycle 4 Day 1 | AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method. |
| Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 | PF-07062119 pre-dose trough concentrations were the serum PF-07062119 concentrations assessed at 0 min of Day 1 and Day 15 in each Cycle. |
| Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5 | Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc.). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1 | Cmax was observed directly from data. |
| Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5 | Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of NAb against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and will be drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for NAb against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). An NAb sample was defined as positive when NAb titer was ≥2. |
| Incidence of ADA Positive Against PF-06801591 | Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment | Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-06801591. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-06801591 in Part 1B were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months. A participant was PF-06801591 ADA positive when ADA titer was ≥99. |
| Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1 | Tumor biospecimens from archival and/de novo biopsies were used to analyze candidate nucleic acid and protein and cellular biomarkers for their ability to inform those participants who were most likely to benefit from treatment with the study interventions. De novo tumor biopsies obtained during therapy and upon disease progression could be used to help confirm pharmacodynamic effects of treatment and investigate potential acquired mechanisms of resistance (ie, presence of but not limited to regulatory T-cells or myeloid derived suppressor cells and other immune suppressive cells or proteins). |
| Number of Participants With Confirmed Objective Response | Baseline up to maximum of 4 years | Tumor assessments included all known or suspected disease sites. Imaging included contrast enhanced chest, abdomen and pelvis CT or MRI scans; brain CT or MRI scan for participants with known or suspected brain metastases; bone scan and/or bone x rays for participants with known or suspected bone metastases. For participants with known CT contrast allergy, a non-contrast CT of the chest with contrast enhanced abdominal and pelvic MRI could be used. The same imaging technique used to characterize each identified and reported lesion at baseline was employed in the tumor assessments. Assessment of response used Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective Response was defined as complete response (CR) + partial response (PR). |
| Titers of ADA Against PF-07062119 | Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment | Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. ADA titers of participants with positive PF-07062119 ADA (titer ≥70) are summarized. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 and Cycle 4 Day 1 | Cmax was observed directly from data. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1 | Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 and Cycle 4 Day 1 | Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence. |
| Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 and Cycle 4 Day 1 | AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method. |
Countries
Australia, Japan, United States
Participant flow
Recruitment details
Dose Expansion Phase (Part 2) of the study was not conducted due to the study termination. Study termination was due to a strategic decision but not any safety concerns or requests from any regulatory authorities.
Participants by arm
| Arm | Count |
|---|---|
| Part 1A PF-07062119 45 µg Participants received PF-07062119 45 µg via subcutaneous (SC) injection as monotherapy every 2 weeks (Q2W) at every cycle (1 cycle=28 days) without a priming dose. | 2 |
| Part 1A PF-07062119 135 µg Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose. | 3 |
| Part 1A PF-07062119 400 µg Participants received PF-07062119 400 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose. | 6 |
| Part 1A PF-07062119 800 µg Participants received PF-07062119 800 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose. | 9 |
| Part 1A PF-07062119 1600 µg Participants received PF-07062119 1600 µg via subcutaneous (SC) injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days). | 2 |
| Part 1A PF-07062119 400 µg/800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 800 µg Q2W since Cycle 1 Day 15. | 10 |
| Part 1A PF-07062119 400 µg/1200 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1200 µg Q2W since Cycle 1 Day 15. | 6 |
| Part 1A PF-07062119 400 µg/1600 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 1600 µg Q2W since Cycle 1 Day 15. | 6 |
| Part 1A PF-07062119 400 µg/2100 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2100 µg Q2W since Cycle 1 Day 15. | 8 |
| Part 1A PF-07062119 400 µg/2800 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 2800 µg Q2W since Cycle 1 Day 15. | 4 |
| PART 1A PF-07062119 400 µg/3700 µg Participants received a priming dose of PF-07062119 400 µg on Cycle 1 Day 1 via SC injection, followed by a full dose of 3700 µg Q2W since Cycle 1 Day 15. | 4 |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W Participants received PF-07062119 400 µg Q2W + PF-06801591 300 mg (50 mg/mL) every 4 weeks (Q4W) via SC injection. | 3 |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection. | 4 |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection. | 4 |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W Participants received PF-07062119 800 µg Q2W via SC injection + bevacizumab-Pfizer via intravenous (IV) infusion Q2W based on 5 mg/kg of body weight. | 5 |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight. | 3 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Global deterioration of health status | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Progressive disease | 2 | 3 | 4 | 7 | 1 | 8 | 4 | 6 | 7 | 3 | 4 | 3 | 4 | 2 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1A PF-07062119 45 µg | Part 1A PF-07062119 135 µg | Part 1A PF-07062119 400 µg | Part 1A PF-07062119 800 µg | Part 1A PF-07062119 1600 µg | Part 1A PF-07062119 400 µg/800 µg | Part 1A PF-07062119 400 µg/1200 µg | Part 1A PF-07062119 400 µg/1600 µg | Part 1A PF-07062119 400 µg/2100 µg | Part 1A PF-07062119 400 µg/2800 µg | PART 1A PF-07062119 400 µg/3700 µg | Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64 Years STANDARD_DEVIATION 16.97 | 60.7 Years STANDARD_DEVIATION 6.03 | 60.8 Years STANDARD_DEVIATION 10.38 | 56.9 Years STANDARD_DEVIATION 10.97 | 41.0 Years STANDARD_DEVIATION 12.73 | 55.9 Years STANDARD_DEVIATION 15.49 | 63.3 Years STANDARD_DEVIATION 15.36 | 55.2 Years STANDARD_DEVIATION 13.11 | 55.5 Years STANDARD_DEVIATION 8.62 | 65.0 Years STANDARD_DEVIATION 11.34 | 62.3 Years STANDARD_DEVIATION 8.54 | 50.3 Years STANDARD_DEVIATION 9.61 | 53.3 Years STANDARD_DEVIATION 14.24 | 54.3 Years STANDARD_DEVIATION 18.8 | 52.2 Years STANDARD_DEVIATION 11.69 | 53.3 Years STANDARD_DEVIATION 9.61 | 56.9 Years STANDARD_DEVIATION 12.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 4 Participants | 8 Participants | 1 Participants | 8 Participants | 6 Participants | 5 Participants | 6 Participants | 3 Participants | 4 Participants | 1 Participants | 4 Participants | 3 Participants | 5 Participants | 2 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 6 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 46 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 4 Participants | 4 Participants | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 30 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 2 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 4 Participants | 1 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 1 / 3 | 5 / 6 | 8 / 9 | 1 / 2 | 6 / 10 | 3 / 6 | 3 / 6 | 1 / 8 | 1 / 4 | 4 / 4 | 2 / 3 | 2 / 4 | 2 / 4 | 2 / 5 | 1 / 3 | 44 / 79 |
| other Total, other adverse events | 2 / 2 | 3 / 3 | 6 / 6 | 9 / 9 | 2 / 2 | 10 / 10 | 5 / 6 | 6 / 6 | 8 / 8 | 4 / 4 | 4 / 4 | 3 / 3 | 4 / 4 | 4 / 4 | 5 / 5 | 3 / 3 | 78 / 79 |
| serious Total, serious adverse events | 0 / 2 | 1 / 3 | 2 / 6 | 3 / 9 | 1 / 2 | 4 / 10 | 4 / 6 | 2 / 6 | 4 / 8 | 1 / 4 | 2 / 4 | 0 / 3 | 0 / 4 | 3 / 4 | 2 / 5 | 1 / 3 | 30 / 79 |
Outcome results
Primary
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: 4 Years
Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 2 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 3 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 2 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 3 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 9 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 4 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 10 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 8 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 3 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 4 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 3 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 4 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 4 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 2 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 5 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TESAEs | 1 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With All-Causality TEAEs | 3 Participants |
Primary
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.
Time frame: 4 Years
Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 3 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 2 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 1 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 1 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 1 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 1 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 2 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 2 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 1 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 2 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 2 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Blood bilirubin increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Creatinine increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alkaline phosphatase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypermagnesemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Aspartate aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Hypomagnesemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Lipase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hyponatremia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Lipase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Alanine aminotransferase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 4 Serum amylase increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities | Grade 3 Hypokalemia | 0 Participants |
Primary
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities
The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.
Time frame: 4 Years
Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 2 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 3 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 2 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 3 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 1 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 3 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Hemoglobin increased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Platelet count decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 Anemia | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 4 Lymphocyte count decreased | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities | Grade 3 White blood cell decreased | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1
Hematological DLTs: * Grade 3 neutropenia lasting \>5 days * Febrile neutropenia defined as an ANC \<1.0 x 10 ̂9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour * Grade ≥3 Neutropenia with infection * Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding * any Grade 4 Thrombocytopenia * Anemia or Thrombocytopenia requiring transfusion Non Hematological DLTs: * Grade ≥3 fatigue lasting ≥7 days * for participants with liver, bone, or lung metastasis, an AST or ALT increase \>8 x ULN or ALP \>10 x ULN; * confirmed DILI meeting Hy's law criteria * Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care * Grade 4 Vomiting or Diarrhea * Grade ≥3 CRS regardless of duration * Grade ≥3 QTcF prolongation irrespective of duration * any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.
Time frame: 28 Days
Population: Analysis population included all enrolled participants who had at least 1 dose of study intervention and either experienced DLT or did not have major treatment deviations during the DLT observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 2 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 2 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 1 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1 | 0 Participants |
Primary
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5.
Time frame: 4 Years
Population: Analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 2 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1A PF-07062119 45 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 3 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 9 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 2 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 2 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 10 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 5 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 6 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 3 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 8 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 3 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 4 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 3 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 4 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 4 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 2 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 5 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TEAEs | 3 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 5 TEAEs | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs | 1 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs | Number of Participants With Treatment-Related TESAEs | 1 Participants |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts
AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 8971 ng•hour/mL | Geometric Coefficient of Variation 38 |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 2994 ng•hour/mL | Geometric Coefficient of Variation 51 |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 22800 ng•hour/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 10570 ng•hour/mL | Geometric Coefficient of Variation 31 |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 2221 ng•hour/mL | Geometric Coefficient of Variation 57 |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 31200 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 3046 ng•hour/mL | Geometric Coefficient of Variation 53 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 15660 ng•hour/mL | Geometric Coefficient of Variation 66 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 26700 ng•hour/mL | Geometric Coefficient of Variation 68 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 4213 ng•hour/mL | Geometric Coefficient of Variation 61 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 95210 ng•hour/mL | Geometric Coefficient of Variation 17 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 117000 ng•hour/mL | — |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 4030 ng•hour/mL | Geometric Coefficient of Variation 26 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 38220 ng•hour/mL | Geometric Coefficient of Variation 17 |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 158000 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 56500 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 4179 ng•hour/mL | Geometric Coefficient of Variation 31 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 24754.80 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 10950 ng•hour/mL | Geometric Coefficient of Variation 42 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 3814 ng•hour/mL | Geometric Coefficient of Variation 33 |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 4277 ng•hour/mL | Geometric Coefficient of Variation 48 |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 15540.785 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 4 Day 1 | 50516.83 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 15 | 18127.33 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts | Cycle 1 Day 1 | 3649 ng•hour/mL | Geometric Coefficient of Variation 20 |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts
AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 6527 ng•hour/mL | Geometric Coefficient of Variation 38 |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 42300 ng•hour/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 5612 ng•hour/mL | Geometric Coefficient of Variation 43 |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 60200 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 7864 ng•hour/mL | Geometric Coefficient of Variation 42 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 168000 ng•hour/mL | — |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 9712 ng•hour/mL | Geometric Coefficient of Variation 52 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 9169 ng•hour/mL | Geometric Coefficient of Variation 14 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 210000 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 304000 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 10030 ng•hour/mL | Geometric Coefficient of Variation 19 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 32500 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 8387 ng•hour/mL | Geometric Coefficient of Variation 37 |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 9233 ng•hour/mL | Geometric Coefficient of Variation 37 |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 4 Day 1 | 89600 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts | Cycle 1 Day 1 | 8887 ng•hour/mL | Geometric Coefficient of Variation 13 |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts
AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 340.04 ng•hour/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 1209 ng•hour/mL | Geometric Coefficient of Variation 5 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 5564 ng•hour/mL | Geometric Coefficient of Variation 56 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 4 Day 1 | 17400 ng•hour/mL | — |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 9041 ng•hour/mL | Geometric Coefficient of Variation 39 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 4 Day 1 | 20700 ng•hour/mL | — |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 16500 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 2684 ng•hour/mL | Geometric Coefficient of Variation 21 |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 4 Day 1 | 9830 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 4 Day 1 | 30900 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts | Cycle 1 Day 1 | 7133 ng•hour/mL | Geometric Coefficient of Variation 40 |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts
AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 802.577 ng•hour/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 2618 ng•hour/mL | Geometric Coefficient of Variation 8 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 12060 ng•hour/mL | Geometric Coefficient of Variation 43 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 4 Day 1 | 32400 ng•hour/mL | — |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 19120 ng•hour/mL | Geometric Coefficient of Variation 35 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 4 Day 1 | 42300 ng•hour/mL | — |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | NA ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 6346.2 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 4 Day 1 | 17100 ng•hour/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 1 Day 1 | 14810 ng•hour/mL | Geometric Coefficient of Variation 30 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts | Cycle 4 Day 1 | 58200 ng•hour/mL | — |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts
Cmax was observed directly from data.
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 2.96 ng/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 9.032 ng/mL | Geometric Coefficient of Variation 10 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 43.67 ng/mL | Geometric Coefficient of Variation 40 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 4 Day 1 | 110 ng/mL | — |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 66.75 ng/mL | Geometric Coefficient of Variation 39 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 4 Day 1 | 164.92 ng/mL | — |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 132.2 ng/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 23.35 ng/mL | Geometric Coefficient of Variation 16 |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 4 Day 1 | 62.9 ng/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 4 Day 1 | 193 ng/mL | — |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts | Cycle 1 Day 1 | 55.96 ng/mL | Geometric Coefficient of Variation 29 |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
Cmax was observed directly from data.
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 27.75 ng/mL | Geometric Coefficient of Variation 52 |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 67.03 ng/mL | Geometric Coefficient of Variation 35 |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 145 ng/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 190 ng/mL | — |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 67.34 ng/mL | Geometric Coefficient of Variation 53 |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 23.66 ng/mL | Geometric Coefficient of Variation 33 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 142.1 ng/mL | Geometric Coefficient of Variation 54 |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 30.98 ng/mL | Geometric Coefficient of Variation 31 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 598.1 ng/mL | Geometric Coefficient of Variation 16 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 37.79 ng/mL | Geometric Coefficient of Variation 53 |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 224.2 ng/mL | Geometric Coefficient of Variation 59 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 36.04 ng/mL | Geometric Coefficient of Variation 16 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 333.9 ng/mL | Geometric Coefficient of Variation 30 |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 744.5 ng/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 987 ng/mL | — |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 38.10 ng/mL | Geometric Coefficient of Variation 16 |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 427.5 ng/mL | Geometric Coefficient of Variation 6 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 26.45 ng/mL | Geometric Coefficient of Variation 13966 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 29.32 ng/mL | Geometric Coefficient of Variation 44 |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 76.74 ng/mL | Geometric Coefficient of Variation 31 |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 92.64 ng/mL | Geometric Coefficient of Variation 60 |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 37.59 ng/mL | Geometric Coefficient of Variation 31 |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 15 | 143.2 ng/mL | Geometric Coefficient of Variation 15 |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 1 Day 1 | 37.37 ng/mL | Geometric Coefficient of Variation 13 |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts | Cycle 4 Day 1 | 326.26 ng/mL | — |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
Time frame: Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 167 Hour |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 19.0 Hour |
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 162 Hour |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 129 Hour |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 222 Hour |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 21.8 Hour |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 152 Hour |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 178 Hour |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 151 Hour |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 165 Hour |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 83.5 Hour |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 131 Hour |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 167 Hour |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 128 Hour |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 26.5 Hour |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 132 Hour |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 167 Hour |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 94.5 Hour |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 111 Hour |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 167 Hour |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 167 Hour |
| Part 1A PF-07062119 400 µg/1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 167 Hour |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 4 Day 1 | 104.2 Hour |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 15 | 73.2 Hour |
| Part 1A PF-07062119 400 µg/2100 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts | Cycle 1 Day 1 | 166 Hour |
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
Time frame: Cycle 1 Day 1 and Cycle 4 Day 1
Population: Number of participants analyzed included all enrolled participants treated with at least 1 PK parameter of interest. Number analyzed refers to number of participants who had PK parameter results with no dose interruption/reduction before or on this visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 173.11 Hour |
| Part 1A PF-07062119 135 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 186 Hour |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 93.3 Hour |
| Part 1A PF-07062119 400 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 4 Day 1 | 95.4 Hour |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 96.8 Hour |
| Part 1A PF-07062119 800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 4 Day 1 | 95.5 Hour |
| Part 1A PF-07062119 1600 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 35.85 Hour |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 170 Hour |
| Part 1A PF-07062119 400 µg/800 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 4 Day 1 | 96.2 Hour |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 4 Day 1 | 23.4 Hour |
| Part 1A PF-07062119 400 µg/1200 µg | Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts | Cycle 1 Day 1 | 94.0 Hour |
Secondary
Incidence of ADA Positive Against PF-06801591
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-06801591. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-06801591 in Part 1B were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months. A participant was PF-06801591 ADA positive when ADA titer was ≥99.
Time frame: Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment
Population: Analysis population included all participants who had ≥1 post-treatment ADA result.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A PF-07062119 45 µg | Incidence of ADA Positive Against PF-06801591 | 0 Percentage |
| Part 1A PF-07062119 135 µg | Incidence of ADA Positive Against PF-06801591 | 0 Percentage |
| Part 1A PF-07062119 400 µg | Incidence of ADA Positive Against PF-06801591 | 0 Percentage |
Secondary
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for ADA against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc.). Participants with an unresolved AE possibly related to ADA were asked to return to the clinic for ADA and drug concentration assessments at approximately 3 month intervals until the AE or its sequelae resolved or stabilized at a level acceptable to the investigator and sponsor up to a maximum of 9 months.
Time frame: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Population: Number of participants analyzed included all enrolled participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants with ≥1 post-treatment ADA result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 45 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 135 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 135 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 16.7 Percentage |
| Part 1A PF-07062119 800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 11.1 Percentage |
| Part 1A PF-07062119 1600 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 1600 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/1200 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/1200 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/1600 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/1600 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 16.7 Percentage |
| Part 1A PF-07062119 400 µg/2100 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/2100 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 25.0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 33.3 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 20.0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119 | Treatment-Induced | 66.7 Percentage |
Secondary
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of NAb against PF-07062119. All samples were collected on Day 1 of a cycle (also on Day 15, in Cycle 1 only) and will be drawn pre-dose - within 6 hours prior to any of the drugs being administered. Starting at Cycle 5, blood samples for NAb against PF-07062119 were collected every 3rd cycle pre-dose (ie, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, etc). An NAb sample was defined as positive when NAb titer was ≥2.
Time frame: Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Population: Number of participants analyzed included all enrolled participants who received at least 1 dose of study intervention. Number analyzed refers to number of participants with ≥1 post-treatment NAb result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 45 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 135 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 135 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 16.7 Percentage |
| Part 1A PF-07062119 800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 1600 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 1600 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/1200 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/1200 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/1600 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 16.7 Percentage |
| Part 1A PF-07062119 400 µg/1600 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/2100 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/2100 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 25.0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 33.3 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Boosted | 0 Percentage |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119 | Treatment-Induced | 66.7 Percentage |
Secondary
Number of Participants With Confirmed Objective Response
Tumor assessments included all known or suspected disease sites. Imaging included contrast enhanced chest, abdomen and pelvis CT or MRI scans; brain CT or MRI scan for participants with known or suspected brain metastases; bone scan and/or bone x rays for participants with known or suspected bone metastases. For participants with known CT contrast allergy, a non-contrast CT of the chest with contrast enhanced abdominal and pelvic MRI could be used. The same imaging technique used to characterize each identified and reported lesion at baseline was employed in the tumor assessments. Assessment of response used Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective Response was defined as complete response (CR) + partial response (PR).
Time frame: Baseline up to maximum of 4 years
Population: Analysis population included all enrolled participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A PF-07062119 45 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 135 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 800 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 1600 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg/800 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg/1200 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg/1600 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg/2100 µg | Number of Participants With Confirmed Objective Response | 1 Participants |
| Part 1A PF-07062119 400 µg/2800 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1A PF-07062119 400 µg/3700 µg | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Number of Participants With Confirmed Objective Response | 0 Participants |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Number of Participants With Confirmed Objective Response | 1 Participants |
Secondary
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies
Tumor biospecimens from archival and/de novo biopsies were used to analyze candidate nucleic acid and protein and cellular biomarkers for their ability to inform those participants who were most likely to benefit from treatment with the study interventions. De novo tumor biopsies obtained during therapy and upon disease progression could be used to help confirm pharmacodynamic effects of treatment and investigate potential acquired mechanisms of resistance (ie, presence of but not limited to regulatory T-cells or myeloid derived suppressor cells and other immune suppressive cells or proteins).
Time frame: Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1
Population: Number of participants analyzed included all enrolled participants with at least 1 of the biomarkers evaluated at pre and/or post dose. Number analyzed refers to number of participants with non-missing test.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A PF-07062119 800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD3+ Cells/mm2 CT+ (cells/mm2) | -34.1 Percentage |
| Part 1A PF-07062119 800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD8+ Cells/mm2 CT+ (cells/mm2) | -23.3 Percentage |
| Part 1A PF-07062119 800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Positive Immune Cells per Tumor Area (%) | 1500.0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD8+ Cells/mm2 CT+ (cells/mm2) | 1848.0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Tumor Cell Membrane Staining (%) | 0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD3+ Cells/mm2 CT+ (cells/mm2) | 456.0 Percentage |
| Part 1A PF-07062119 400 µg/2800 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Positive Immune Cells per Tumor Area (%) | -20.0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD3+ Cells/mm2 CT+ (cells/mm2) | 482.2 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD8+ Cells/mm2 CT+ (cells/mm2) | 1378.5 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Positive Immune Cells per Tumor Area (%) | 700.0 Percentage |
| Part 1A PF-07062119 400 µg/3700 µg | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Tumor Cell Membrane Staining (%) | -100.0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | PD-L1 Positive Immune Cells per Tumor Area (%) | -100.0 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD8+ Cells/mm2 CT+ (cells/mm2) | 28.4 Percentage |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies | CD3+ Cells/mm2 CT+ (cells/mm2) | 39.6 Percentage |
Secondary
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119
PF-07062119 pre-dose trough concentrations were the serum PF-07062119 concentrations assessed at 0 min of Day 1 and Day 15 in each Cycle.
Time frame: Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1
Population: Analysis population included all enrolled participants who were treated and had at least 1 analyte concentration.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A PF-07062119 45 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 2.850 ng/mL |
| Part 1A PF-07062119 45 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 3.265 ng/mL |
| Part 1A PF-07062119 45 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 5.25 ng/mL |
| Part 1A PF-07062119 135 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 14.5 ng/mL |
| Part 1A PF-07062119 135 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 21.9 ng/mL |
| Part 1A PF-07062119 135 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 20.6 ng/mL |
| Part 1A PF-07062119 135 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 8.140 ng/mL |
| Part 1A PF-07062119 135 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 11.00 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 74.45 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 77.8 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 80.2 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 74.9 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 82.1 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 49.7 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 68.50 ng/mL |
| Part 1A PF-07062119 400 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 39.40 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 117 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 122 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 91.45 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 74.45 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 114.5 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 107.0 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 128.0 ng/mL |
| Part 1A PF-07062119 800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 56.95 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 111.0 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 76.90 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 133 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 129.0 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 112 ng/mL |
| Part 1A PF-07062119 1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 47.40 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 128.0 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 19.80 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 104.0 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 121.0 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 74.10 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 108.0 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 94.40 ng/mL |
| Part 1A PF-07062119 400 µg/800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 125.0 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 110.0 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 90.50 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 162.0 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 130.0 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 69.80 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 22.55 ng/mL |
| Part 1A PF-07062119 400 µg/1200 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 161.0 ng/mL |
| Part 1A PF-07062119 400 µg/1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 100.0 ng/mL |
| Part 1A PF-07062119 400 µg/1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 26.25 ng/mL |
| Part 1A PF-07062119 400 µg/1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 126.0 ng/mL |
| Part 1A PF-07062119 400 µg/1600 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 188.5 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 11 Day 1 | 636.0 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 25.30 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 453.0 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 322.0 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 176.5 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 414.0 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 431.5 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 429.5 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 357.0 ng/mL |
| Part 1A PF-07062119 400 µg/2100 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 8 Day 1 | 517.5 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 542.5 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 24.40 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 263.5 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 432.0 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 497.0 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 528.5 ng/mL |
| Part 1A PF-07062119 400 µg/2800 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 517.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 706.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 559.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 795.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 242.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 528.0 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 30.40 ng/mL |
| Part 1A PF-07062119 400 µg/3700 µg | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 358.0 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 16.60 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 37.20 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 36.40 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 40.80 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 27.95 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 34.6 ng/mL |
| Part 1B PF-07062119 400 µg Q2W + PF-06801591 300 mg Q4W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 35.6 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 72.10 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 77.50 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 69.35 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 75.80 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 57.70 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 94.40 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 29.80 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 94.00 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 54.80 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 22.3 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 87.00 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 63.25 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 11 Day 1 | 189.0 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 92.45 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 150.5 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 149.0 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 44.20 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 110.0 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 147.0 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 8 Day 1 | 179.0 ng/mL |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 141.0 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 1 | 181.5 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 8 Day 1 | 125.0 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 1 | 245.5 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 15 | 153.0 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 5 Day 1 | 217.5 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 3 Day 15 | 225.5 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 4 Day 15 | 226.0 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 1 Day 15 | 26.30 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 2 Day 1 | 101.0 ng/mL |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Pre-dose Trough Concentrations After Multiple Doses of PF-07062119 | Cycle 11 Day 1 | 98.50 ng/mL |
Secondary
Titers of ADA Against PF-07062119
Blood samples of approximately 4 mL, to provide a minimum of serum 2 mL, were collected for determination of ADA against PF-07062119. ADA titers of participants with positive PF-07062119 ADA (titer ≥70) are summarized.
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
Population: Number of participants analyzed included all participants who had ≥1 post-treatment ADA result. Number analyzed refers to number of participants with ADA-positive samples (titer ≥70).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A PF-07062119 400 µg | Titers of ADA Against PF-07062119 | End of Treatment | 4291 titers |
| Part 1A PF-07062119 800 µg | Titers of ADA Against PF-07062119 | Cycle 2 Day 1 | 197 titers |
| Part 1A PF-07062119 400 µg/1600 µg | Titers of ADA Against PF-07062119 | Cycle 4 Day 1 | 439158 titers |
| Part 1A PF-07062119 400 µg/1600 µg | Titers of ADA Against PF-07062119 | Cycle 3 Day 1 | 34295 titers |
| Part 1A PF-07062119 400 µg/2800 µg | Titers of ADA Against PF-07062119 | End of Treatment | 392 titers |
| Part 1A PF-07062119 400 µg/2800 µg | Titers of ADA Against PF-07062119 | Cycle 1 Day 1 | 326 titers |
| Part 1A PF-07062119 400 µg/2800 µg | Titers of ADA Against PF-07062119 | Cycle 1 Day 15 | 257 titers |
| Part 1A PF-07062119 400 µg/3700 µg | Titers of ADA Against PF-07062119 | Cycle 2 Day 1 | 544 titers |
| Part 1A PF-07062119 400 µg/3700 µg | Titers of ADA Against PF-07062119 | End of Treatment | 134678 titers |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | Cycle 2 Day 1 | 427 titers |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | Cycle 4 Day 1 | 16761 titers |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | Cycle 1 Day 1 | 121 titers |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | Cycle 3 Day 1 | 1063 titers |
| Part 1B PF-07062119 800 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | Cycle 1 Day 15 | 540 titers |
| Part 1B PF-07062119 1200 µg Q2W + PF-06801591 300 mg Q4W-Priming | Titers of ADA Against PF-07062119 | End of Treatment | 2413 titers |
| Part 1B PF-07062119 800 µg Q2W + Bevacizumab 5 mg/kg Q2W | Titers of ADA Against PF-07062119 | End of Treatment | 197 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | End of Treatment | 344 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | Cycle 5 Day 1 | 70 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | Cycle 8 Day 1 | 140562 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | Cycle 11 Day 1 | 120976 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | Cycle 14 Day 1 | 351572 titers |
| Part 1B PF-07062119 1200 µg Q2W + Bevacizumab 5 mg/kg Q2W-Priming | Titers of ADA Against PF-07062119 | Cycle 17 Day 1 | 155181 titers |