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

Trial details

Who runs it

Pfizer

Trial code

NCT04458259

Record updated

4 June 2026

Original description

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid TumorsRead full original descriptionShow less

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

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

Inclusion: 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: 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; Uncontrolled HTN that cannot be controlled by medications; Inability to consume or absorb study drug; Prohibited concomitant medications as defined in protocol; Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption; 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:; 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; Known or suspected hypersensitivity to PF-07265807; Active bleeding disorder; Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis; Known active uncontrolled or symptomatic CNS metastases.

ClinicalTrials.gov NCT04458259