drugset / Trial / NCT07066098

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

NCT07066098

Phase 3 Recruiting 201 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.

Timeline

Start
2025-08-04
Primary completion
2027-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI343 Monoclonal antibody 6 mg/kg Intravenous