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A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

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Trial Profile

A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

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

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Capecitabine (Primary) ; Cisplatin (Primary) ; Fluorouracil (Primary) ; Oxaliplatin (Primary) ; Tislelizumab (Primary) ; Trastuzumab (Primary) ; Zanidatamab (Primary) ; Antineoplastics
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERIZON-GEA-01
  • Sponsors Jazz Pharmaceuticals Inc; Zymeworks

Most Recent Events

  • 15 Jun 2025 Planned primary completion date changed from 15 May 2025 to 15 Oct 2025.
  • 31 Mar 2025 Status changed from recruiting to active, no longer recruiting.
  • 27 Feb 2025 According to BeiGene media release, company anticipate primary PFS data readout from Phase 3 study in first-line HER2-positive gastroesophageal adenocarcinoma in the second half of 2025.

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