Clinical Trial

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

Study acronym: HERIZON-GEA-01
Active, Not Recruiting Phase 3
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Record status
This record was last updated July 17, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
Protocol Amendment History 59 amendments
This ClinicalTrials.gov record has been amended 59 times since 2021-12-03; most recent amendment 2026-07-16.
Status change: Recruiting → Active, Not Recruiting 2025-03-31
Trial Details
NCT Number NCT05152147
Lead Sponsor Jazz Pharmaceuticals
Collaborators: BeOne Medicines LTD, BeOne Pharmaceutical Co., Ltd.
Conditions Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
Enrollment 920 participants
Start Date 2021-12-02
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-17