Study of PF-07265807 in Participants With Metastatic Solid Tumors.
a study on Neoplasm Metastasis Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedcompletion around
Description
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
Official Title
A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
Keywords
Neoplasm Metastasis, 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), Axitinib, Sasanlimab
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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.
Locations
- UC Irvine Health
Orange California 92868-3201 United States - UC Irvine Medical Center
Orange California 92868-3201 United States - UC Irvine Health
Orange California 92868 United States - UCI Chao Family Comprehensive Cancer Center
Orange California 92868 United States - UCI Medical Center- Outpatient Pharmacy
Orange California 92868 United States - UCI/Chao Family Comprehensive Cancer Center
Orange California 92868 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Pfizer
- Links
- To obtain contact information for a study center near you, click here.
- ID
- NCT04458259
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- About 67 people participating
- Last Updated