C6461008 - AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Condition studied

ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Investigational medicinal product(s)

Eligibility

Primary endpoint

Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator, Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s), Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1), Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)., Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator

Endpoint detail

Cohort A: - Duration of response (DoR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS), Cohort A: Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Cohort A: Predose and post dose concentrations of PF-08634404., Cohort A: Incidence of antidrug antibodies (ADA) against PF-08634404, Cohort B/C: - DoR using RECIST 1.1 as assessed by investigator - PFS using RECIST 1.1 as assessed by investigator - OS, Cohort B/C: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Cohort B/C: Predose and post dose concentrations of PF-08634404, Cohort B/C: Incidence of ADA against PF-08634404