Clinical Trial

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)

Study acronym: G-HOPE-001
Active, Not Recruiting Phase 3
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Summary
This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-01-25; most recent amendment 2026-05-08.
Status change: Recruiting → Active, Not Recruiting 2026-05-08
Status change: Enrolling by Invitation → Recruiting 2025-08-19
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-07-22
Trial Details
NCT Number NCT06238843
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Enrollment 464 participants
Start Date 2024-06-30
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-13