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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2026

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At a glance

  • Drugs Arcotatug tavatecan (Primary) ; Irinotecan; Paclitaxel
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms G-HOPE-001
  • Sponsors Innovent Biologics

Most Recent Events

  • 04 Jun 2026 According to an Innovent Biologics Media Release, clinical study data are planned to be published in future academic conferences or journals.
  • 04 Jun 2026 According to an Innovent Biologics Media Release, Based on the positive clinical results, Innovent has submitted the new drug application (NDA) for arcotatug tavatecan to the National Medical Products Administration (NMPA) of China, for the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) and the application was accepted with priority review.
  • 04 Jun 2026 Primary endpoint (progression free survival(PFS)) has been met, according to an Innovent Biologics media release.

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