A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (HERIZON-GEA-01)

May 15, 2026 updated by: Jazz Pharmaceuticals

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
920

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, 1264
        • Hospital de Gastroenterología Dr Bonorino Udaondo
      • Buenos Aires, Argentina, C1012
        • Instituto de Investigaciones Metabólicas - IDIM
      • Córdoba, Argentina, X5008HHW
        • Centro Medico Privado CEMAIC
      • Córdoba, Argentina, X5000HXL
        • Fundación Centro de Medicina Nuclear y Molecular ER
      • Pergamino, Argentina, 2700
        • Centro de Investigacion Pergamino S.A.
      • Viedma, Argentina, R8500ACE
        • Centro de Investigación Clínica - Clínica Viedma
  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Heidelberg, Australia, 3084
        • Austin Health
      • Liverpool, Australia, 2170
        • Liverpool Hospital
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda VZW
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liège
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundação Pio XII Hospital de Câncer de Barretos
      • Barretos, Brazil, 14784-400
        • Centro Integrado de Pesquisa - CIP
      • Belo Horizonte, Brazil, 30130-090
        • Cenantron - Centro Avancado de Tratamento Oncologico Ltda
      • Brasília, Brazil, 70840-901
        • Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho
      • Fortaleza, Brazil, 60430-230
        • Instituto Do Câncer Do Ceará ICC
      • Porto Alegre, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceição
      • Porto Alegre, Brazil, 90050-170
        • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
      • Santo André, Brazil, 09060-650
        • Núcleo de Pesquisa Clínica da Rede São Camilo
      • Sorocaba, Brazil, 18030-075
        • Instituto de Oncologia de Sorocaba
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de São Paulo ICESP
  • Canada
      • Toronto, Canada, M5G 2C1
        • Princess Margaret Cancer Centre
  • Chile
      • Providencia, Chile, 7500000
        • Centro de Estudios Clínicos SAGA SpA
      • Santiago, Chile, 7500000
        • Sociedad Oncovida S.A
      • Santiago, Chile, 8150513
        • Icegclinic
      • Santiago, Chile, 8330336
        • BIOCINETIC SpA
      • Temuco, Chile, 4810469
        • Sociedad de Investigaciones Médicas Limitada
    • Region Metropolitan
      • Santiago, Region Metropolitan, Chile, 8420383
        • Centro Internacional de Estudios Clinicos CIEC
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500000
        • Fundación Arturo López Pérez (FALP) - PPDS
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, China, 101199
        • Beijing Luhe Hospital, Capital Medical University
      • Beijing, China, 100020
        • Beijing Chao-yang Hospital, Capital Medical University
      • Bengbu, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Changsha, China, 410031
        • Hunan Cancer Hospital
      • Changzhi, China, 046099
        • Changzhi People's Hospital
      • Changzhou, China, 213004
        • Changzhou First People's Hospital
      • Chengdu, China, 610042
        • Sichuan Cancer Hospital & Institute
      • Fuzhou, China, 350014
        • Fujian Cancer Hospital
      • Fuzhou, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University
      • Guangzhou, China, 510655
        • the sixth affiliated hospital of Sun Yat-sen University
      • Guangzhou, China, 510055
        • Guangdong Provincial People's Hospital
      • Haikou, China, 570311
        • Hainan General Hospital
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Hangzhou, China, 310017
        • Second Affiliated Hospital of Zhejiang University School of Medicine
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230031
        • Anhui Provincial Cancer Hospital
      • Hefei, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
      • Hohhot, China, 01000
        • Affiliated Hospital of Inner Mongolia Medical University
      • Jinan, China, 250013
        • Jinan Central Hospital
      • Jinan, China, 250000
        • Shandong Cancer Hospital
      • Kunming, China, 650118
        • Yunnan Cancer Hospital
      • Lanzhou, China, 730050
        • Gansu Cancer Hospital
      • Lanzhou, China, 730013
        • The First Hospital of Lanzhou University
      • Nanchang, China, 330052
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
      • Qingdao, China, 266003
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200080
        • Shanghai General Hospital
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200032
        • Fudan University Affiliated Zhongshan Hospital
      • Shenyang, China, 110801
        • Liaoning Cancer Hospital & Institute
      • Shijiazhuang, China, 50011
        • The Fourth Hospital of Hebei Medical University
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Tianjin, China, 300041
        • Tianjin Medical University General Hospital
      • Tonghua, China, 143099
        • The Tonghua Central Hospital
      • Weihai, China, 264200
        • Weihai Municipal Hospital
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, China, 430023
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuxi, China, 214062
        • Affiliated Hospital of Jiangnan University
      • Xi'an, China, 710061
        • First Affiliated Hospital of Xi 'an Jiaotong University
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Yangzhou, China, 225001
        • Northern Jiangsu People's Hospital
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, China, 450003
        • Henan Cancer Hospital
      • Ürümqi, China, 830026
        • Cancer Hospital Affiliated to Xinjiang Medical University
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation
  • France
      • Avignon, France, 84000
        • Sainte-Catherine, Institut du Cancer Avignon Provence
      • Bordeaux, France, 33000
        • EDOG - Institut Bergonie - PPDS
      • Dijon, France, 21079
        • Universite de Bourgogne - Faculte de Medecine - IN
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
      • Lyon, France, 69008
        • Centre Leon Berard
      • Nantes, France, 44805
        • EDOG Institut de Cancerologie de l'Ouest - PPDS
      • Poitiers, France, 86021
        • CHRU de Poitiers La Miletrie
      • Rennes, France, 35000
        • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
      • Saint-Priest-en-Jarez, France, 42270
        • CHRU de Brest - Hopital Morvan
      • Toulouse, France, 69437
        • Hôpital de Rangueil
      • Villejuif, France, 94800
        • Hôpital Saint Antoine
    • Gironde
      • Pessac, Gironde, France, 33600
        • CHU de Bordeaux - Hôpital Haut Leveque
  • Georgia
      • Tbilisi, Georgia, 0112
        • Research Institute of Clinical Medicine
      • Tbilisi, Georgia, 6000
        • High Technology Hospital MedCenter Ltd
  • Germany
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Institut für Klinisch-Onkologische Forschung
  • Greece
      • Athens, Greece, 124 64
        • Attikon University General Hospital
      • Thessaloniki, Greece, 552 36
        • Agios Loucas Clinic SA
      • Thessaloniki, Greece, 54622
        • Bioclinic Thessaloniki Oncology Department
      • Thessaloniki, Greece, 57001
        • Interbalkan Medical Center of Thessaloniki Oncology Department
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Clinica Medica Especializada CELAN
      • Guatemala City, Guatemala, 01015
        • Grupo Medico Angeles
      • Salcajá, Guatemala, 09002
        • Centro Medico Integral de Cancerologia CEMIC
  • India
      • Bhubaneswar, India, 751019
        • All India Institute of Medical Sciences, Bhubaneswar
      • Gurgaon, India, 122003
        • Artemis Hospital
      • Hyderabad, India, 500004
        • MNJ Institute of Oncology and Regional Cancer Centre
      • New Delhi, India, 110076
        • Indraprastha Apollo Hospitals
      • Patna, India, 800014
        • Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
      • Vijayawada, India, 520002
        • HCG City Cancer Center
  • Ireland
      • Dublin, Ireland, 8
        • St James's Hospital
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Candiolo, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia (IRCCS)
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
      • Milan, Italy, 20133
        • Istituto Nazionale dei Tumori
      • Milan, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
      • Modena, Italy, 41124
        • Azienda Ospedaliero Universitaria Di Modena Policlinico
      • Reggio Emilia, Italy, 43100
        • Arcispedale Santa Maria Nuova
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli
      • Verona, Italy, 37134
        • Centro Ricerche Cliniche di Verona
      • Vicenza, Italy, 36100
        • Azienda ULSS 8 "Berica" - Ospedale San Bortolo
  • Japan
      • Chūōku, Japan, 104-0045
        • National Cancer Center Hospital
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Ina, Japan, 362-0806
        • Saitama Cancer Center
      • Matsuyama, Japan, 791-0245
        • Shikoku Cancer Center
      • Osaka, Japan, 540-0008
        • Osaka International Cancer Institute
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Ōsaka-sayama, Japan, 589-0014
        • Kindai University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-0801
        • Chiba Cancer Center
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Gihu
      • Gifu, Gihu, Japan, 501-1112
        • Gifu University Hospital
    • Gunma
      • Ota-shi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hyôgo
      • Akashi-shi, Hyôgo, Japan, 673-8558
        • Hyogo Cancer Center
    • Ibaraki
      • Kasama-Shi, Ibaraki, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital
    • Kagawa-ken
      • Kita-Gun Miki-Cho, Kagawa-ken, Japan, 761-0701
        • Kagawa University Hospital
    • Kanagawa
      • Yokohama-Shi Asahi-Ku, Kanagawa, Japan, 241-0815
        • Kanagawa Cancer Center
    • Kumamoto
      • Chuo-Ku, Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital - Honjo-Kuhonji Campus A
    • Kyoto-shi
      • Sakyo-ku, Kyoto-shi, Japan, 606-8507
        • Kyoto University Hospital
    • Miyagi
      • Osaki-Shi, Miyagi, Japan, 989-6136
        • Osaki Citizen Hospital
    • Okayama-ken
      • Kurashiki-Shi, Okayama-ken, Japan, 710-0052
        • Kurashiki Central Hospital
    • Osaka
      • Suita-Shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Takatsuki-Shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Malaysia
      • George Town, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kuching, Malaysia, 93586
        • Sarawak General Hospital
      • Putrajaya, Malaysia, 62675
        • National Cancer Institute ( Institut Kanser Negara)
  • Mexico
      • Mexico City, Mexico, 03100
        • Health Pharma Professional Research S.A de C.V.
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
      • Oaxaca City, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
      • Tilburg, Netherlands, 5042 AD
        • ETZ-Elisabeth
  • Poland
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
      • Warsaw, Poland, 02-034
        • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
  • Portugal
      • Almada, Portugal, 2801-951
        • Hospital Garcia de Orta
      • Coimbra, Portugal, 3000-459
        • Centro Hospitalar E Universitario de Coimbra EPE
      • Guimarães, Portugal, 4830-044
        • Hospital Senhora da Oliveira - Guimaraes, E.P.E
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Matosinhos Municipality, Portugal, 4454-509
        • Unidade Local de Saúde de Matosinhos SA
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto EPE
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute
      • Cluj-Napoca, Romania, 400641
        • Medisprof SRL
      • Cluj-Napoca, Romania, 400015
        • Prof Dr I Chiricuta Institute of Oncology - PPDS
      • Craiova, Romania, 200347
        • Oncology Center Sfantul Nectarie
  • Serbia
      • Belgrade, Serbia, 11070
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia - PPDS
      • Kamenitz, Serbia, 21204
        • Oncology Institute of Vojvodina
      • Niš, Serbia, 18000
        • University Clinical Center Nis
  • Singapore
      • Singapore, Singapore, 258500
        • National Cancer Center Singapore
  • South Africa
      • Pretoria, South Africa, 0184
        • Wilgers Oncology Centre
  • South Korea
      • Anyang-si, South Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seongnam-si, South Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 03080
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 03686
        • Severance Hospital Yonsei University Health System - PPDS
      • Seoul, South Korea, 06229
        • Gangnam Severance Hospital, Yonsei University Health System
  • Spain
      • Badalona, Spain, 8915
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr Josep Trueta
      • L'Hospitalet de Llobregat, Spain, 08908
        • Institut Català d'Oncologia (Hospital Duran y Reynals)
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz - PPDS
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital General
      • Salamanca, Spain, 32911
        • Complejo Asistencial Universitario de Salamanca - H. Clinico
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Complejo Hospitalario de Navarra
  • Taiwan
      • Taichung, Taiwan, 404472
        • China Medical University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • Thailand
      • Hat Yai, Thailand, 90110
        • Songklanagarind Hospital
      • Khon Kaen, Thailand, 40000
        • Srinagarind Hospital, Khon Kaen University
      • Lak Si, Thailand, 10210
        • Chulaborn Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi Kanser Enstitusu
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty
      • Izmir, Turkey (Türkiye), 35220
        • Dokuz Eylul Universitesi
      • Seyhan, Turkey (Türkiye), 01130
        • Acibadem Adana Hospital
      • Trabzon, Turkey (Türkiye), 61310
        • Medical Park Trabzon Yildizli
      • Yenimahalle, Turkey (Türkiye), 06200
        • Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital Edinburgh - PPDS
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
      • London, United Kingdom, SW7 3RP
        • Royal Marsden Hospital - London
      • London, United Kingdom, SW7 3RP
        • Royal Marsden Hospital - Surrey
      • Peterborough, United Kingdom, PE3 9GZ
        • Edith Cavell Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
  • Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
  • Adequate organ function
  • Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)

Exclusion Criteria:

  • Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
  • Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
  • Known history of or ongoing leptomeningeal disease (LMD)
  • Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
  • Known active hepatitis
  • Any history of human immunodeficiency virus (HIV) infection
  • Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
  • QTc Fridericia (QTcF) > 470 ms
  • Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm A
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Drug: Cisplatin
Administered IV
Drug: Trastuzumab
Administered intravenously (IV)
Other Names:
  • Herceptin®
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Experimental: Arm B
Zanidatamab plus physician's choice of CAPOX or FP
Drug: Cisplatin
Administered IV
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Drug: Zanidatamab
Administered IV
Other Names:
  • ZW25
  • JZP598
  • ZIIHERA®
Experimental: Arm C
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Drug: Cisplatin
Administered IV
Drug: Capecitabine
Administered orally (PO bid)
Drug: Oxaliplatin
Administered IV
Drug: 5-Fluorouracil
Administered IV
Drug: Zanidatamab
Administered IV
Other Names:
  • ZW25
  • JZP598
  • ZIIHERA®
Drug: Tislelizumab
Administered IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 3.5 years
The time from randomization to death due to any cause
Up to 3.5 years
Progression-free survival (PFS) by BICR
Time Frame: Up to 2.5 years
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
Up to 2.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Confirmed objective response rate (ORR) by BICR
Time Frame: Up to 2.5 years
Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR
Up to 2.5 years
Duration of response (DOR) by BICR
Time Frame: Up to 2.5 years
The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause
Up to 2.5 years
PFS per Investigator assessment
Time Frame: Up to 2.5 years
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause
Up to 2.5 years
DOR per Investigator assessment
Time Frame: Up to 2.5 years
The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause
Up to 2.5 years
Incidence of adverse events
Time Frame: Up to 2 years
Number of subjects who experienced adverse events or serious adverse events
Up to 2 years
Incidence of clinical laboratory abnormalities
Time Frame: Up to 2 years
Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Up to 2 years
Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC QLQ-C30 scores
Up to 2.5 years
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC QLQ-OG25 scores
Up to 2.5 years
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Time Frame: Up to 2.5 years
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores
Up to 2.5 years
Incidence of anti-drug antibodies (ADAs)
Time Frame: Up to 2 years
Number of patients who develop ADAs
Up to 2 years
Confirmed ORR per Investigator assessment
Time Frame: Up to 2.5 years
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator
Up to 2.5 years
Serum concentration of zanidatamab and tislelizumab
Time Frame: Up to 2 years
Up to 2 years
Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR
Time Frame: Up to 2.5 years
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
Up to 2.5 years
Assessment of Contribution of Components based on Overall Survival
Time Frame: Up to 3.5 years
The time from randomization to death due to any cause
Up to 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BeOne Medicines LTD
BeOne Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jonathan Grim, MD, PhD, Zymeworks Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZWI-ZW25-301
  • 2021-000296-36 (EudraCT Number)
  • jRCT2061230026 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))
  • 2023-510319-20-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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