A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
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).
Timeline
- Start
- 2021-12-02
- Primary completion
- 2026-07-15
- Completion
- 2027-09-30
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper P<0.001 for both comparisons). reads as mixed primary results PMID 42202319 ↗
paper Overall survival was longer with zanidatamab-tislelizumab-chemotherapy than with trastuzumab-chemotherapy reads as mixed primary results PMID 42202319 ↗
paper overall survival did not differ significantly between zanidatamab-chemotherapy (median, 24.4 months) and trastuzumab-chemotherapy reads as mixed primary results PMID 42202319 ↗
release “HERIZON-GEA-01 trial in combination with ZIIHERA (zanidatamab) and chemotherapy, demonstrating statistically significant and clinically meaningful improvement in overall survival” reads as met primary endpoint beonemedicines.com ↗
Publications
- Shitara K, Elimova E, Liu T, Tabernero J, Lee KW, Schenker M, Tebbutt NC, Ajani J, Salimin N, Ku G, Gwang Kim J, Ales Diaz I, Zhang J, Pietrantonio F, Bai LY, Le Sourd S, Zhao J, Hierro C, Kiberu A, Van Herpe F, Bao Y, Zhang H, Yang L, Li V, Gartner EM, Chen Y, Grim J, Rha SY, Shen L; HERIZON-GEA-01 Investigators. Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer. N Engl J Med. 2026 May 28;394(20):2002-2014. doi: 10.1056/NEJMoa2517729.
- Lee KW, Bai LY, Jung M, Ying J, Im YH, Oh DY, Cho JY, Oh SC, Chao Y, Kim JW, Chen Y, Li V, Chen S, Kang YK. Phase Ib/II Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2026 Jan 16;32(2):312-323. doi: 10.1158/1078-0432.CCR-24-4295.
- Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
- Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo +/- tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future Oncol. 2022 Sep;18(29):3255-3266. doi: 10.2217/fon-2022-0595. Epub 2022 Aug 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | — | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Zanidatamab | Monoclonal antibody | — | Intravenous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Oxaliplatin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |