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

Brief 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).

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

HERIZON-GEA-01

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

920

sponsor

Jazz Pharmaceuticals

conditions

Gastric Neoplasms; Gastroesophageal Adenocarcinoma; Esophageal Adenocarcinoma

interventions

DRUG: Zanidatamab; DRUG: Tislelizumab; DRUG: Trastuzumab; DRUG: Capecitabine; DRUG: Oxaliplatin; DRUG: Cisplatin; DRUG: 5-Fluorouracil

start date

2021-12-02

start date type

ACTUAL

primary completion date

2026-07-15

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters