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)

Phase 3 Active not recruiting 464 enrolled Innovent Biologics (Suzhou) Co. Ltd.

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 2024-06-30
Primary completion: 2026-12-30
Completion: 2027-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IBI343	Monoclonal antibody	6 mg/kg	Intravenous
Comparator	Irinotecan	Small molecule	150 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Comparator	Trifluridine/tipiracil	Unknown	35 mg/m2	Oral

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)

Summary

Timeline

Drugs

Indications