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TerminatedPhase 1NCT04458259
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-07265807 and Sasanlimab

Plus 1 other study approaches.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 4, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Pfizer
Interventions being studied
Drug: PF-07265807; Drug: Sasanlimab; Drug: Axitinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
  • 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.
Reasons someone may not be able to joinExclusion 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.
  • 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.
  • Prior treatment with selective AXL/MERTK inhibitors For participants receiving sasanlimab: \- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Henry Eye ClinicFayetteville, Arkansas
  • Highlands Oncology GroupFayetteville, Arkansas
  • Highlands Oncology GroupRogers, Arkansas
  • Highlands Oncology GroupSpringdale, Arkansas
  • UCI Chao Family Comprehensive Cancer CenterOrange, California
  • Clinical & Translational Science InstituteSan Francisco, California
  • UCSF Helen Diller Family Comprehensive Cancer Center - Mission HallSan Francisco, California
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
  • Rocky Mountain Lions Eye Institute (RMLEI)Aurora, Colorado
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, Colorado
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Aurora, Colorado
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Aurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 4, 2026. Always confirm current availability with the study team.

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