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

• Status: Recruiting
• Trial end date: 2024-01-23
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib

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.

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.