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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
StatusActive, Not Recruiting
PhasePhase 3
Started2021-12-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 31, 2026 → Sep 30, 2026
See other at-risk trials from Jazz Pharmaceuticals

Amendment history

The 50 most recent of 61 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-28
Study Status, IPDSharing v60
Primary completion confirmed: July 2026 (last estimated September 2026)
Primary completion pushed: 2026-07-31 → 2026-09-30
Completion pushed: 2027-07-31 → 2027-09-30
2026-07-16
2 amendments v58-v59
2 re-verifications since 2026-06-29, no change to tracked fields
2026-05-15
Study Status, Contacts/Locations v57
Study sites227 entries, revised
TheMunicipal MunicipalNon-profit Enterprise Volyn"City RegionalClinical MedicalHospital Oncology# Centre4" of theDnipro Volyn RegionalCity Council - PPDS
2026-04-15
2 amendments v55-v56
2 re-verifications since 2026-03-23, no change to tracked fields
2026-02-26
Study Status, Contacts/Locations v54
Study sites226→227
Show 43 earlier versions
2026-01-16
2 amendments v52-v53
2 re-verifications since 2025-12-16, no change to tracked fields
2025-12-09
Study Status v51
Primary completion date2025-12-01→2026-07-31
Completion date2026-05-15→2027-07-31
2025-11-21
Study Status v50
Re-verified, no change to tracked fields
2025-10-20
Study Status, Sponsor/Collaborators v49
Primary completion date2025-10-15→2025-12-01
Collaborators3 to 2 entries
BeiGene
2025-09-23
Study Status v48
Re-verified, no change to tracked fields
2025-08-28
Study Identification, Study Status, Sponsor/Collaborators v47
Collaborators1 to 3 entries
BeOne Medicines LTD BeOne Pharmaceutical Co., Ltd.
2025-07-29
Study Status, Contacts/Locations v46
Study sites227→226
2025-06-26
Study Status v45
Re-verified, no change to tracked fields
2025-06-12
Study Status, Arms and Interventions v44
Primary completion date2025-05-15→2025-10-15
2025-04-22
Study Status v43
Re-verified, no change to tracked fields
2025-03-31
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v42
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 918→confirmed 920
Study sites313→227
2025-02-18
Study Status v41
Re-verified, no change to tracked fields
2025-01-17
Study Status, Sponsor/Collaborators, Contacts/Locations v40
Study sites321→313
Collaborators1 entry, revised
BeOne MedicinesBeiGene
2024-12-20
Study Status, Contacts/Locations v39
Primary completion date2024-12-31→2025-05-15
Completion date2025-07-01→2026-05-15
Study sitesdetails revised at 93 of 321 sites
2024-11-15
Study Status v38
Re-verified, no change to tracked fields
2024-10-21
Study Status, Contacts/Locations v37
Study sitesdetails revised at 1 of 321 sites
2024-09-09
Study Status, Contacts/Locations v36
Study sites319→321
2024-08-19
Study Status, Contacts/Locations v35
Study sites317→319
2024-07-18
Study Status, Contacts/Locations v34
Study sites316→317
2024-06-18
Study Status, Contacts/Locations v33
Completion date2026-02-01→2025-07-01
Study sites316 entries, revised
HospitalCentro Integrado de BasePesquisa Da- FaculdadeCIP Centro de MedicinaPesquisas deClínicas/Fundação São José Do Rio Preto HospitalDoutor Amaral Carvalho Associação Hospital de Caridade Ijuí Instituto Brasileiro de Controle Do Câncer IBCC James LindONCOSITE Centro de InvestigaciónPesquisa delClínica CáncerEm Oncologia Núcleo de Pesquisa Clínica da Rede São Camilo Sociedad de Investigaciones Medicas Limitada Sainte-Catherine, Institut du Cancer Avignon Provence Institut SainteCatalà Catherine ICOd'Oncologia l'Hospitalet - (Hospital Duran iy Reynals) Bangkok Metropolitan Administration Medi [...] [...]
2024-05-31
Study Status, Contacts/Locations v32
Study sitesdetails revised at 1 of 316 sites
2024-05-17
Study Status, Study Design, Outcome Measures, Contacts/Locations v31
Primary completion date2024-06-01→2024-12-31
Completion date2025-07-01→2026-02-01
Enrollment target714→918
Study sites314→316
Secondary endpoints12 to 14 entries
Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR Assessment of Contribution of Components based on Overall Survival
Primary endpoints2 entries, revised
Progression-free survival (PFS) by blinded independent central review (BICR)
2024-03-25
Study Status, Contacts/Locations v30
Study sites313→314
2024-03-22
Study Status, Contacts/Locations v29
Study sites305→313
2024-03-04
Study Status, Contacts/Locations v28
Study sites291→305
2024-01-10
Study Status, Contacts/Locations v27
Study sites289→291
2023-11-16
Study Status, Arms and Interventions, Contacts/Locations v26
Study sites292→289
Interventions5-Fluorouracil (Drug), Capecitabine (Drug), Cisplatin (Drug), Immunohistochemistry (IHC)-based companion diagnostic assay (Diagnostic…→5-Fluorouracil (Drug), Capecitabine (Drug), Cisplatin (Drug), Oxaliplatin (Drug), Tislelizumab (Drug), Trastuzumab (Drug), Zanidatamab…
2023-10-25
Study Status, Oversight, Contacts/Locations v25
Primary completion date2024-06→2024-06-01
Completion date2025-07→2025-07-01
Study sites290→292
2023-10-12
Study Status, Conditions, Arms and Interventions, Contacts/Locations v24
Study sites282→290
2023-08-11
Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Eligibility, Contacts/Locations v23
Study sites281→282
Lead sponsorZymeworks BC Inc.→Jazz Pharmaceuticals
Eligibility criteria+43 characters
[...] athways Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic [...] ed brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically sta [...]
Secondary endpoints12 entries, revised
Confirmed ORR per Investigator assessment Serum concentration of zanidatamab, tislelizumab, and trastuzumabtislelizumab
2023-04-03
Study Status, Contacts/Locations v22
Study sites291→281
2023-03-02
Study Status, Contacts/Locations v21
Study sites292→291
2023-01-30
Study Status, Contacts/Locations v20
Study sites294→292
2022-12-15
Study Status, Contacts/Locations v19
Study sites294 entries, revised
ResearchInstituto Sitedo Cancer do Estado de São Paulo ICESP ResearchPrincess SiteMargaret Cancer Centre ResearchHospital SitePulau Pinang
2022-11-25
Study Status, Contacts/Locations v18
Study sites294 entries, revised
ResearchSt SiteJames's Hospital ResearchAzienda SiteOspedaliero Universitaria Di Modena Policlinico
2022-11-10
Study Status, Contacts/Locations v17
Study sites295→294
2022-10-20
Study Status, Contacts/Locations v16
Study sites292→295
2022-10-07
Study Status, Contacts/Locations v15
Study sites294→292
2022-09-23
Study Status, Contacts/Locations v14
Study sites294 entries, revised
Centro de Investigación Clínica - Clínica Viedma Instituto Do Câncer Do Ceará ICC Peking Union Medical College Hospital Artemis Hospital MNJ Institute of Oncology and Regional Cancer Centre Regional Cancer Centre Indira Gandhi Institute of Medical Sciences Deenanath Mangeshkar Hospital and Research SiteCentre Ospedale 1Policlinico San Martino ResearchOncocare SiteCancer 2 Research Site Research Site Research Site Research Site Research Site Research site 1 Research site 2Centre
2022-09-13
Study Status, Contacts/Locations v13
Study sites294 entries, revised
ResearchShanghai Site10th 3People's Hospital ResearchShangrao SitePeople's Hospital ResearchBangkok SiteMetropolitan 1Administration Medical College and Vajira Hospital ResearchPhramongkutklao SiteHospital Prince 2of Songkla University ResearchChulaborn site Research siteHospital
2022-08-31
Study Status, Contacts/Locations v12
Study sites294 entries, revised
ResearchHospital Sitede 3Clinicas de Porto Alegre (HCPA) - PPDS ResearchIrmandade SiteDa 4Santa Casa de Misericordia de Porto Alegre ResearchBeijing SiteHospital The 3First People's Hospital of Changzhou ResearchThe SiteFirst Affiliated Hospital, College of Medicine, Zhejiang University ResearchCurie SiteManavata Cancer Centre ResearchHCG SiteCity Cancer Center ResearchASST SiteGrande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda ResearchUniversity Siteof 3 Research sitePretoria
2022-08-09
Study Status, Contacts/Locations v11
Study sites294 entries, revised
ResearchHarbin SiteMedical University Cancer Hospital ResearchShanghai SiteEast 4Hospital ResearchFakultni Sitenemocnice Olomouc ResearchUniversite Sitede Bourgogne - Faculte de Medecine - IN ResearchCelan SiteS.A. ResearchCryptex SiteInvestigación 3Clínica, S.A. de C.V. ResearchHospital SiteUniversitario Dr. Jose Eleuterio González ResearchCentro Sitede Investigacion Clinica de Oaxaca ResearchSt siteJames University Hospital
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).
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 2026-07-15 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24