Study to Test the Safety and Tolerability of PF-07062119... | NCT04171141 | Trialant
NCT04171141
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jan 16, 2025Actual
Enrollment
79Actual
Phase
Phase 1
Conditions
Gastrointestinal Tumors
Colorectal Adenocarcinomas
Gastric Adenocarcinomas
Esophageal Adenocarcinomas
Interventions
PF-07062119
Anti-PD1
Anti-VEGF
Countries
United States
Australia
Japan
Protocol Section
Identification Module
NCT ID
NCT04171141
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3861001
Secondary IDs
ID
Type
Description
Link
GUCY2C
Other Identifier
Alias Study Number
Brief Title
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Official Title
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was terminated due to strategic considerations and not due to safety.
Expanded Access Info
No
Start Date
Nov 19, 2019Actual
Primary Completion Date
Nov 28, 2023Actual
Completion Date
Nov 28, 2023Actual
First Submitted Date
Nov 8, 2019
First Submission Date that Met QC Criteria
Nov 18, 2019
First Posted Date
Nov 20, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Nov 13, 2024
Results First Submitted that Met QC Criteria
Jan 13, 2025
Results First Posted Date
Jan 16, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 13, 2025
Last Update Posted Date
Jan 16, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
Conditions Module
Conditions
Gastrointestinal Tumors
Colorectal Adenocarcinomas
Gastric Adenocarcinomas
Esophageal Adenocarcinomas
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
79Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation
Experimental
Single Agent Dose Escalation
Drug: PF-07062119
Dose Finding Anti-PD-1 Combination
Experimental
Part 1B PF-07062119 plus anti-PD-1
Drug: PF-07062119
Drug: Anti-PD1
Dose Finding anti-VEGF Combination
Experimental
Part 1B PF-07062119 plus anti-VEGF
Drug: PF-07062119
Drug: Anti-VEGF
Dose Expansion Arm A
Experimental
PF-07062119 as a Single Agent in CRC
Drug: PF-07062119
Dose Expansion Arm B
Experimental
PF-07062119 in Combination with anti-PD-1 in CRC
Drug: PF-07062119
Dose Expansion Arm C
Experimental
PF-07062119 in Combination with anti-VEGF in CRC
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-07062119
Drug
PF-07062119
Dose Escalation
Dose Expansion Arm A
Dose Expansion Arm B
Dose Expansion Arm C
Dose Expansion Arm D
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
28 Days
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.
4 Years
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.
Secondary Outcomes
Measure
Description
Time Frame
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte
California
91010
United States
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
Part 1A PF-07062119 135 µg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 19, 2021
Nov 13, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: PF-07062119
Drug: Anti-PD1
Drug: Anti-VEGF
Dose Expansion Arm D
Experimental
PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
Drug: PF-07062119
Drug: Anti-PD1
Drug: Anti-VEGF
Dose Finding Anti-PD-1 Combination
Dose Finding anti-VEGF Combination
Anti-PD1
Drug
Anti-PD1 PF-06801591
Dose Expansion Arm C
Dose Expansion Arm D
Dose Finding Anti-PD-1 Combination
Anti-VEGF
Drug
Anti-VEGF IV (bevacizumab)
Dose Expansion Arm C
Dose Expansion Arm D
Dose Finding anti-VEGF Combination
4 Years
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.
4 Years
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.
4 Years
Cmax was observed directly from data.
Cycle 1 Day 1 and Cycle 4 Day 1
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.
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
Cycle 1 Day 1 and Cycle 4 Day 1
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.
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 Day 1 and Cycle 4 Day 1
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.
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 Day 1 and Cycle 4 Day 1
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.
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
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.
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
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.
Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
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.
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
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.
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
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).
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
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).
Baseline up to maximum of 4 years
City of Hope IDS Pharmacy
Duarte
California
91010
United States
UCLA Department of Medicine: Hematology-Oncology
Los Angeles
California
90055
United States
UCLA Hematology Oncology - Santa Monica
Santa Monica
California
90404
United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora
Colorado
80045
United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora
Colorado
80045
United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora
Colorado
80045
United States
START Midwest
Grand Rapids
Michigan
49546
United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York
New York
10022
United States
Evelyn H. Lauder Breast and Imaging Center
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York
New York
10065
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Christus Santa Rosa Hospital
San Antonio
Texas
78229
United States
NEXT Oncology
San Antonio
Texas
78229
United States
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
National Cancer Center Hospital East
Kashiwa
Chiba
277-8577
Japan
National Cancer Center Hospital
Chuo-ku
Tokyo
104-0045
Japan
Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.
FG002
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.
FG003
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.
FG004
Part 1A PF-07062119 1600 µg
Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).
FG005
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.
FG006
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.
FG007
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.
FG008
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.
FG009
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.
FG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
FG0002 subjects
FG0013 subjects
FG0026 subjects
FG0039 subjects
FG0042 subjects
FG00510 subjects
FG0066 subjects
FG0076 subjects
FG0088 subjects
FG0094 subjects
FG0104 subjects
FG0113 subjects
FG0124 subjects
FG0134 subjects
FG0145 subjects
FG0153 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0026 subjects
FG0039 subjects
FG0042 subjects
FG00510 subjects
FG0066 subjects
FG0076 subjects
FG0088 subjects
FG0094 subjects
FG0104 subjects
FG0113 subjects
FG0124 subjects
FG0134 subjects
FG0145 subjects
FG0153 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0132 subjects
FG0140 subjects
FG0150 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0002 subjects
FG0013 subjects
FG0024 subjects
FG0037 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Global deterioration of health status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Baseline analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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).
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
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.
BG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0013
BG0026
BG0039
BG0042
BG00510
BG0066
BG0076
BG0088
BG0094
BG0104
BG0113
BG0124
BG0134
BG0145
BG0153
BG01679
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00064± 16.97
BG00160.7± 6.03
BG00260.8± 10.38
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Count of Participants
Participants
28 Days
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
Part 1A PF-07062119 1600 µg
Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).
OG005
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.
OG006
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.
Units
Counts
Participants
OG0002
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
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.
Analysis population included all enrolled participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
4 Years
ID
Title
Description
OG000
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.
OG001
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.
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.
Analysis population included all enrolled participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
4 Years
ID
Title
Description
OG000
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.
OG001
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.
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.
Analysis population included all enrolled participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
4 Years
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis population included all enrolled participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
4 Years
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
Cmax was observed directly from data.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
Part 1A PF-07062119 800 µg
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.
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.
Posted
Median
Full Range
Hour
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Tmax was time at which Cmax occurred which was observed directly from data as time of first occurrence.
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.
Posted
Median
Full Range
Hour
Cycle 1 Day 1 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hour/mL
Cycle 1 Day 1 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, determined using linear/Log trapezoidal method.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hour/mL
Cycle 1 Day 1 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hour/mL
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
AUC168 was area under the serum concentration-time profile from Day 1 to Day 7 (168 hours) determined using linear/Log trapezoidal method.
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.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hour/mL
Cycle 1 Day 1 and Cycle 4 Day 1
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis population included all enrolled participants who were treated and had at least 1 analyte concentration.
Posted
Median
Full Range
ng/mL
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
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
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.
Posted
Number
Percentage
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
ID
Title
Description
OG000
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.
OG001
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.
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.
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).
Posted
Median
Full Range
titers
Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
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.
Posted
Number
Percentage
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
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Analysis population included all participants who had ≥1 post-treatment ADA result.
Posted
Number
Percentage
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
Participants received PF-07062119 800 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.
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).
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.
Posted
Median
Full Range
Percentage
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
ID
Title
Description
OG000
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.
OG001
Part 1A PF-07062119 135 µg
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).
Analysis population included all enrolled participants.
Posted
Count of Participants
Participants
Baseline up to maximum of 4 years
ID
Title
Description
OG000
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.
OG001
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.
OG002
Time Frame
4 Years
Description
Same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. Safety analysis set included all participants who took at least 1 dose of study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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
2
0
2
2
2
EG001
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.
1
3
1
3
3
3
EG002
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.
5
6
2
6
6
6
EG003
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.
8
9
3
9
9
9
EG004
Part 1A PF-07062119 1600 µg
Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).
1
2
1
2
2
2
EG005
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.
6
10
4
10
10
10
EG006
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.
3
6
4
6
5
6
EG007
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.
3
6
2
6
6
6
EG008
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.
1
8
4
8
8
8
EG009
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.
1
4
1
4
4
4
EG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
1
3
1
3
3
3
EG016
Total
Overall Population
44
79
30
79
78
79
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sinus tachycardia
Cardiac disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG0030 affected9 at risk
EG0040 affected2 at risk
EG0050 affected10 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected8 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected4 at risk
EG0130 affected4 at risk
EG0140 affected5 at risk
EG0150 affected3 at risk
EG0161 affected79 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Disease progression
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG0030 affected9 at risk
EG0040 affected2 at risk
EG0051 affected10 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0080 affected8 at risk
EG0091 affected4 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected4 at risk
EG0130 affected4 at risk
EG0140 affected5 at risk
EG0150 affected3 at risk
EG0166 affected79 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0024 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0023 affected6 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal perforation
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal stenosis
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Asthenia
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Axillary pain
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Early satiety
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0024 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site discolouration
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site dryness
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection site erythema
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected3 at risk
EG0026 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Injection site pruritus
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0024 affected6 at risk
EG003
Injection site rash
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Injection site reaction
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Malaise
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pre-existing condition improved
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0024 affected6 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bacillus infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Post procedural diarrhoea
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
White blood cell count increased
Investigations
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0023 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0012 affected3 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA version 26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
This study was terminated on 10 October 2023. Study termination was due to a strategic decision but not any safety concerns or requests from any regulatory authorities. This BR presents the study results of dose escalation phase (Part 1) collected by the study completion date (28-Nov-2023). Dose expansion phase (Part 2) of the study was not conducted due to the study termination.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
9
OG0042
OG0056
OG0063
OG0074
OG0087
OG0093
OG0102
OG0113
OG0124
OG0132
OG0145
OG0153
2
OG0042
OG0051
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG002
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Number of Participants With All-Causality TEAEs
Title
Measurements
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Number of Participants With All-Causality TESAEs
Title
Measurements
OG0000
OG0011
OG0022
OG003
Number of Participants With Maximum Grade 3 or 4 TEAEs
Title
Measurements
OG0000
OG0011
OG0023
OG003
Number of Participants With Maximum Grade 5 TEAEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG002
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Number of Participants With Treatment-Related TEAEs
Title
Measurements
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Number of Participants With Treatment-Related TESAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Number of Participants With Treatment-Related Maximum Grade 3 or 4 TEAEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Number of Participants With Treatment-Related Maximum Grade 5 TEAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Grade 3 Lymphocyte count decreased
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0041
OG0053
OG0060
OG0073
OG0081
OG0090
OG0101
OG0110
OG0120
OG0131
OG0143
OG0150
Grade 4 Lymphocyte count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Anemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 3 Hemoglobin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 White blood cell decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Platelet count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
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.
OG004
Part 1A PF-07062119 1600 µg
Participants received PF-07062119 1600 µg via SC injection as monotherapy without a priming dose Q2W at every cycle (1 cycle=28 days).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Grade 3 Alanine aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
Grade 3 Alkaline phosphatase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 3 Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 4 Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 3 Creatinine increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypermagnesemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Hypokalemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 4 Hypomagnesemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 3 Hyponatremia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 Lipase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Lipase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Grade 3 Serum amylase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4 Serum amylase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG003
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.
OG004
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.
OG005
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.
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.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG0053
OG0065
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0065
Title
Measurements
OG0002.96± NATwo participants with evaluable Cmax results at this visit (2.93 and 3.00 ng/mL), so the geometric %CV was NA.
OG0019.032± 10
OG00243.67± 40
OG003
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
OG003
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.
OG004
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.
OG005
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.
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.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG0053
OG0065
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0065
Title
Measurements
OG000173.11(8.22 to 338)
OG001186(94.7 to 191)
OG00293.3(90.7 to 387)
OG003
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
OG003
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.
OG004
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.
OG005
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.
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.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG0053
OG0065
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0065
Title
Measurements
OG000802.577± NATwo participants with evaluable AUCtau results at this visit (765 and 842 ng•hour/mL), so the geometric %CV was NA.
OG0012618± 8
OG00212060± 43
OG003
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
OG003
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.
OG004
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.
OG005
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.
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.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG0053
OG0065
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0065
Title
Measurements
OG000340.04± NATwo participants with evaluable AUC168 results at this visit (298 and 388 ng•hour/mL), so the geometric %CV was NA.
OG0011209± 5
OG0025564± 56
OG003
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0038
ParticipantsOG0040
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG0104
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0145
ParticipantsOG0153
Title
Measurements
OG0002.850(2.77 to 2.93)
OG0018.140(6.85 to 8.54)
OG00239.40(31.7 to 48.1)
OG003
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0038
Cycle 2 Day 15
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0036
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 4 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 5 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 8 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 11 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0134
OG0145
OG0153
Title
Denominators
Categories
Treatment-Induced
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
ParticipantsOG0042
ParticipantsOG0059
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0088
ParticipantsOG0094
ParticipantsOG0104
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0145
ParticipantsOG0153
Title
Measurements
OG0000
OG0010
OG00216.7
OG003
Treatment-Boosted
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0039
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG0059
OG0066
OG0076
OG0088
OG0094
OG0104
OG0113
OG0124
OG0133
OG0145
OG0153
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0121
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG009326(326 to 326)
OG012121(121 to 121)
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 4 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 5 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 5 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 8 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 11 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 14 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 17 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
End of Treatment
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W + PF-06801591 300 mg (50 mg/mL) Q4W via SC injection.
Units
Counts
Participants
OG0003
OG0014
OG0021
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Participants received PF-07062119 135 µg via SC injection as monotherapy Q2W at every cycle (1 cycle=28 days) without a priming dose.
OG002
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.
Participants received PF-07062119 1200 µg Q2W via SC injection + bevacizumab-Pfizer via IV infusion Q2W based on 5 mg/kg of body weight.
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0039
OG0042
OG00510
OG0066
OG0076
OG0088
OG0094
OG0103
OG0113
OG0124
OG0134
OG0144
OG0153
Title
Denominators
Categories
CD3+ Cells/mm2 CT+ (cells/mm2)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0101
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0141
ParticipantsOG0150
Title
Measurements
OG003-34.1(-34.1 to -34.1)
OG009456.0(89.1 to 822.8)
OG010482.2(482.2 to 482.2)
OG014
CD8+ Cells/mm2 CT+ (cells/mm2)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
PD-L1 Tumor Cell Membrane Staining (%)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PD-L1 Positive Immune Cells per Tumor Area (%)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
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.
OG003
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.
OG004
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).
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
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.