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Experimental cancer drug trial halted early

NCT ID NCT04458259

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called PF-07265807 in people with advanced or metastatic solid tumors that had spread. The main goals were to find a safe dose and check for side effects. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

88 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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. 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. * 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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 colorectal cancer colorectal neoplasm cutaneous neuroendocrine carcinoma endometrium neoplasm Esophageal Neoplasms gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma hepatocellular carcinoma melanoma metastatic malignant neoplasm metastatic neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma renal cell carcinoma small cell lung carcinoma transitional cell carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasm metastasis

Contacts and locations

Locations

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Clinical & Translational Science Institute

    San Francisco, California, 94158, United States

  • Community Health Network Cancer Center North

    Indianapolis, Indiana, 46250, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46219, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Duke University Medical Center, lnvestigational Chemotherapy Service

    Durham, North Carolina, 27710, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, ROME, 00168, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • 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

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale

    Naples, 80131, Italy

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Rocky Mountain Lions Eye Institute (RMLEI)

    Aurora, Colorado, 80045, United States

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCI Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall

    San Francisco, California, 94158, United States

  • University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.