Phase 3 Study of IBI343 With Best Supportive Care Versus Placebo in Adults with Claudin 18.2-Positive Advanced or Metastatic Pancreatic Cancer After Prior Treatments

What this Trial Is About

Researchers are evaluating IBI343 monotherapy combined with best supportive care in people with Claudin 18.2-positive locally advanced unresectable or metastatic pancreatic cancer who have already tried at least two prior treatments. This study is a multicenter, randomized, double-blind, phase III trial aiming to compare overall survival between those receiving IBI343 plus best supportive care and those receiving placebo plus best supportive care. Participants will be randomly assigned in a 21 ratio to receive either IBI343 or placebo. Both treatments are given as a 6 mgkg intravenous infusion on day 1 of a 3-week cycle. The study plans to enroll approximately 201 participants who will continue to receive best supportive care alongside the assigned study treatment. Throughout the study, participants will be monitored for about 24 months to assess overall survival as the primary outcome. Secondary measures include progression-free survival, response rates, duration and timing of response, adverse events, and drug concentration levels in the blood. Researchers will also evaluate immunogenicity and other pharmacokinetic parameters. Safety and treatment effects will be closely followed during regular visits and assessments.

A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)