Study of PF-07265807 in Participants With Metastatic Solid Tumors.
- Conditions
- Solid Tumor
- Registration Number
- JPRN-jRCT2031210442
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
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.
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
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method