A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma

Condition studied

Adult participants with metastatic PDAC with KRAS G12D mutation

Investigational medicinal product(s)

Eligibility

Primary endpoint

Overall Survival (OS), defined as the time from the date of randomization until the date of death from any cause

Endpoint detail

Progression-free survival (PFS) per RECIST v1.1, as assessed by the investigator, TIPP, EORTC QLQ-PAN26, TWGQ, EORTC QLQ-C30, Objective response rate (ORR) per RECIST v1.1, as assessed by the investigator, Safety and tolerability evaluated via the following: AEs, SAEs, laboratory test results, ECGs, vital signs and ECOG Performance Status, End of infusion concentration and Ctrough, Change from baseline in EORTC QLQ-PAN26, EORTC QLQ-C30, EQ-5D-5L, PGIC and PGIS