Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring TAMK (TAM kinase), MER (mer proto-oncogene), MERTK (mer proto-oncogene tyrosine kinase), AXL (AXL receptor tyrosine kinase), AXL/MER, Selective kinase inhibitor, PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1), Immune modulator, Advanced Cancer, Metastatic Cancer, Solid Tumor Cancer, Metastatic Solid Tumor, Cervical Cancer, Gastric Cancer, Esophageal Cancer, Endometrial Cancer, Hepatocellular carcinoma (HCC), Melanoma, Merkel Cell Carcinoma, High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Renal cell carcinoma (RCC), Urothelial carcinoma, Colorectal cancer (CRC)
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.
For Part 2, Part 3, and Part 4, Cohorts 2-4:
- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
Sites / Locations
- Henry Eye Clinic
- Highlands Oncology Group
- Highlands Oncology Group
- Highlands Oncology Group
- UC Irvine Health
- UC Irvine Medical Center
- UC Irvine Health
- UCI Chao Family Comprehensive Cancer Center
- UCI Medical Center- Outpatient Pharmacy
- UCI/Chao Family Comprehensive Cancer Center
- Clinical & Translational Science Institute
- UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
- UCSF Helen Diller Family Comprehensive Cancer Center
- UCSF Investigational Drugs Pharmacy
- Rocky Mountain Lions Eye Institute (RMLEI)
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
- Community Health Network, Inc.
- Community Health Network, Inc.
- Community Health Network Cancer Center North
- Community Health Network Investigational Drug Services
- Community Health Network, Inc.
- Community Health Network, Inc.
- Massachusetts General Hospital
- Brigham & Women's Hospital
- Dana Farber Cancer Institute
- Dana-Farber Cancer Institute - Chestnut Hill
- Hackensack University Medical Center
- John Theurer Cancer Center at Hackensack University Medical Center
- Duke Eye Center
- Duke University Medical Center
- The University of Texas M. D. Anderson Cancer Center
- HPS Pharmacies Darlinghurst
- Macquarie University
- St Vincent's Hospital
- Calvary Mater Newcastle
- Cross Cancer Institute
- Hamilton Health Sciences-Juravinski Cancer Centre
- University Health Network
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
- CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
- Guangdong Provincial People's Hospital
- Jilin Province Tumor Hospital
- Azienda Ospedaliero Universitaria delle Marche
- Fondazione IRCCS San Gerardo dei Tintori
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
- Istituto Europeo di Oncologia IRCCS
- Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
- Chayagasaka Eye Clinic
- National Cancer Center Hospital East
- Aichi Cancer Center Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Asan Medical Center
- Severance Hospital, Yonsei University Health System
- Severance Hospital
- Hospital Universitari Vall d'Hebron
- Hospital Universitario Fundacion Jimenez Díaz
- Hospital Universitario HM Sanchinarro
- Hospital Clinico Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Monotherapy Dose Escalation: Part 1
Doublet Dose Escalation: Part 2
Triplet Dose Escalation: Part 3
Expansion Phase: Part 4, Cohort 1
Expansion Phase: Part 4, Cohort 2
Expansion Phase: Part 4, Cohort 3
Expansion Phase: Part 4, Cohort 4
Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
PF-07265807 monotherapy in participants with METex14 mutant NSCLC.
PF-07265807 with sasanlimab in participants with MSS CRC
PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
PF-07265807 with sasanlimab plus axitinib in participants with RCC