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Study of PF-07265807 in Participants With Metastatic Solid Tumors. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT04458259•Pfizer

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+4 more criteria

Exclusion Criteria

•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.
+8 more criteria

Locations (33)

Henry Eye Clinic

Fayetteville, Arkansas, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

UCI Chao Family Comprehensive Cancer Center

Orange, California, United States

Clinical & Translational Science Institute

San Francisco, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall

San Francisco, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Rocky Mountain Lions Eye Institute (RMLEI)

Aurora, Colorado, United States

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Key Dates

Start Date

September 24, 2020

Primary Completion Date

November 15, 2024

Completion Date

November 15, 2024

Last Updated

August 28, 2025

Enrollment

ACTUAL participants

Conditions

Neoplasm Metastasis

Interventions

PF-07265807

DRUG

Sasanlimab

DRUG

Axitinib

DRUG

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NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

A Study of LY4175408 in Participants With Advanced Cancer

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