Study Stopped
Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
3 other identifiers
interventional
88
5 countries
33
Brief Summary
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2020
Longer than P75 for phase_1
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2024
CompletedAugust 28, 2025
August 1, 2025
4.1 years
June 24, 2020
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Baseline through day 21 or 42
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline through approximately 2 years
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline through approximately 2 years
Part 4: Overall Response Rate (ORR)
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Part 4, Cohort 4: Complete Response (CR)
Response will be evaluated via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Secondary Outcomes (29)
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Through study completion, an average of 1 year
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Through study completion, an average of 1 year
- +24 more secondary outcomes
Study Arms (7)
Monotherapy Dose Escalation: Part 1
EXPERIMENTALMonotherapy dose escalation of PF-07265807 in participants with select tumor types.
Doublet Dose Escalation: Part 2
EXPERIMENTALDoublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
Triplet Dose Escalation: Part 3
EXPERIMENTALTriplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
Expansion Phase: Part 4, Cohort 1
EXPERIMENTALPF-07265807 monotherapy in participants with METex14 mutant NSCLC.
Expansion Phase: Part 4, Cohort 2
EXPERIMENTALPF-07265807 with sasanlimab in participants with MSS CRC
Expansion Phase: Part 4, Cohort 3
EXPERIMENTALPF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
Expansion Phase: Part 4, Cohort 4
EXPERIMENTALPF-07265807 with sasanlimab plus axitinib in participants with RCC
Interventions
Given 2 weeks on/1 week off
Given SC Q3W
Dosed per package label starting with 5 mg PO BID
Eligibility Criteria
You may qualify if:
- At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
- ECOG Performance Status 0 or 1, 2 with approval
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
- Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
- Life expectancy of at least 3 months.
- Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
- Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
- Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
- Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.
You may not qualify if:
- Known active uncontrolled or symptomatic CNS metastases.
- Any other active malignancy within 2 years prior to enrollment.
- Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
- Active or history of autoimmune disease requiring \>10mg/day prednisone or other concurrent immunosuppressive therapy.
- Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
- Retinal or other serious ophthalmic disorders as defined in protocol.
- Clinically significant cardiac disease as defined in protocol.
- Uncontrolled HTN that cannot be controlled by medications.
- Inability to consume or absorb study drug.
- Known or suspected hypersensitivity to PF-07265807.
- Prohibited concomitant medications as defined in protocol.
- Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
- Active bleeding disorder.
- Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
- Experienced \>= G3 treatment-related irAE with prior PD-(L)1 agent.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (33)
Henry Eye Clinic
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Clinical & Translational Science Institute
San Francisco, California, 94158, United States
UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
San Francisco, California, 94158, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Rocky Mountain Lions Eye Institute (RMLEI)
Aurora, Colorado, 80045, 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
Community Health Network, Inc.
Indianapolis, Indiana, 46219, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46227, United States
Community Health Network Cancer Center North
Indianapolis, Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46256, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02459, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Duke Eye Center
Durham, North Carolina, 27705, United States
Duke University Medical Center, lnvestigational Chemotherapy Service
Durham, North Carolina, 27710, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, ROME, 00168, Italy
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Napoli, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Fundacion Jimenez Díaz
Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2020
First Posted
July 7, 2020
Study Start
September 24, 2020
Primary Completion
November 15, 2024
Study Completion
November 15, 2024
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
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.