Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Active, not recruiting
- Conditions
- Solid Tumor
- Registration Number
- jRCT2031210442
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 155
Inclusion 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
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. For Part 2, Part 3, and Part 4, Cohorts 2-4:
- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
- Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
- Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Number of participants with dose limiting toxicities (DLTs) Baseline through day 21 or 42 DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Number of participants with treatment emergent adverse events (AEs) Baseline through approximately 2 years AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Number of participants with laboratory abnormalities Baseline through approximately 2 years Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Overall Response Rate (ORR) Baseline through approximately 2 years Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Complete Response (CR) Baseline through approximately 2 years Response will be evaluated via radiographical tumor assessment by RECIST v1.1
- Secondary Outcome Measures
Name Time Method