C6461016 - A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

Condition studied

LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 2; Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by investigator, Phase 2; Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0), timing, seriousness, and relationship to study intervention, Phase 3; PFS using RECIST 1.1 as assessed by BICR, Phase 3; OS

Endpoint detail

Phase 2; - 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), Phase 2; Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing, Phase 2; Predose and postdose concentrations of PF-08634404, Phase 2; Incidence of anti-drug antibodies (ADA) against PF-08634404, Phase 3; - ORR using RECIST 1.1 as assessed by BICR and by investigator - PFS using RECIST 1.1 as assessed by investigator - DOR using RECIST 1.1 as assessed by BICR and by investigator - PFS2 (PFS after, Phase 3; - AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s) - Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing, Phase 3; Predose and postdose concentrations of PF-08634404, Phase 3; Incidence of ADA against PF- 08634404, Phase 3; - Change from baseline in Functional Assessment of Cancer Therapy – Gastric (FACT-Ga) Total score and Gastric Cancer Subscale (GaCS) score - Time to definitive deterioration in FACT-Ga total score - Time to definitive deterioration in Gastric