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Terminated NCT04458259

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

Conditions: Neoplasm Metastasis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 88
Sponsor: Pfizer

Location: Henry Eye Clinic Fayetteville Arkansas

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 Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04458259). StuddyBuddy aggregates publicly available trial information.