Status:
TERMINATED
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Lead Sponsor:
Pfizer
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04458259
Start Date
September 24 2020
End Date
November 15 2024
Last Update
August 28 2025
Active Locations (33)
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1
Henry Eye Clinic
Fayetteville, Arkansas, United States, 72703
2
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
3
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
4
Highlands Oncology Group
Springdale, Arkansas, United States, 72762