A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
NCT ID: NCT05152147
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
920 participants
INTERVENTIONAL
2021-12-02
2027-07-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Trastuzumab
Administered intravenously (IV)
Capecitabine
Administered orally (PO bid)
Oxaliplatin
Administered IV
Cisplatin
Administered IV
5-Fluorouracil
Administered IV
Arm B
Zanidatamab plus physician's choice of CAPOX or FP
Zanidatamab
Administered IV
Capecitabine
Administered orally (PO bid)
Oxaliplatin
Administered IV
Cisplatin
Administered IV
5-Fluorouracil
Administered IV
Arm C
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Zanidatamab
Administered IV
Tislelizumab
Administered IV
Capecitabine
Administered orally (PO bid)
Oxaliplatin
Administered IV
Cisplatin
Administered IV
5-Fluorouracil
Administered IV
Interventions
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Zanidatamab
Administered IV
Tislelizumab
Administered IV
Trastuzumab
Administered intravenously (IV)
Capecitabine
Administered orally (PO bid)
Oxaliplatin
Administered IV
Cisplatin
Administered IV
5-Fluorouracil
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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BeOne Medicines LTD
UNKNOWN
BeOne Pharmaceutical Co., Ltd.
UNKNOWN
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Hospital de Gastroenterología Dr Bonorino Udaondo
Buenos Aires, , Argentina
Instituto de Investigaciones Metabólicas - IDIM
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Fundación Centro de Medicina Nuclear y Molecular ER
Córdoba, , Argentina
Centro Médico Privado CEMAIC
Córdoba, , Argentina
Centro de Investigación Pergamino S.A.
Pergamino, , Argentina
Centro de Investigación Clínica - Clínica Viedma
Viedma, , Argentina
Flinders Medical Centre
Bedford Park, , Australia
Austin Health
Heidelberg, , Australia
Liverpool Hospital
Liverpool, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Imelda VZW
Bonheiden, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
Centro Integrado de Pesquisa - CIP
Barretos, , Brazil
Fundação Pio XII Hospital de Câncer de Barretos
Barretos, , Brazil
Cenantron - Centro Avancado de Tratamento Oncologico Ltda
Belo Horizonte, , Brazil
Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho
Brasília, , Brazil
Instituto Do Câncer Do Ceará ICC
Fortaleza, , Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, , Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Nossa Senhora Da Conceição
Porto Alegre, , Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
Santo André, , Brazil
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo, , Brazil
Instituto de Oncologia de Sorocaba
Sorocaba, , Brazil
Princess Margaret Cancer Centre
Toronto, , Canada
Centro Internacional de Estudios Clinicos CIEC
Santiago, Region Metropolitan, Chile
Fundación Arturo López Pérez (FALP) - PPDS
Providencia, Santiago Metropolitan, Chile
Centro de Estudios Clínicos SAGA SpA
Providencia, , Chile
Sociedad Oncovida S.A
Santiago, , Chile
Icegclinic
Santiago, , Chile
BIOCINETIC SpA
Santiago, , Chile
Sociedad de Investigaciones Medicas Limitada
Temuco, , Chile
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Luhe Hospital, Capital Medical University
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Hunan Cancer Hospital
Changsha, , China
Changzhi People's Hospital
Changzhi, , China
Changzhou First People's Hospital
Changzhou, , China
Sichuan Cancer Hospital & Institute
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
Fujian Cancer Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Hainan General Hospital
Haikou, , China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Cancer Hospital
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, , China
Shandong Cancer Hospital
Jinan, , China
Jinan Central Hospital
Jinan, , China
Yunnan Cancer Hospital
Kunming, , China
The First Hospital of Lanzhou University
Lanzhou, , China
Gansu Cancer Hospital
Lanzhou, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Ruijin hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Fudan University Affiliated Zhongshan Hospital
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
The Tonghua Central Hospital
Tonghua, , China
Cancer Hospital affiliated to Xinjiang Medical University
Ürümqi, , China
Weihai Municipal Hospital
Weihai, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Union Hospital Tongji Medical College HuaZhong University of Science and Technology
Wuhan, , China
Hubei Cancer Hospital
Wuhan, , China
Affiliated Hospital of Jiangnan University
Wuxi, , China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
North Estonia Medical Centre Foundation
Tallinn, , Estonia
CHU de Bordeaux - Hopital Haut Leveque
Pessac, Gironde, France
Sainte-Catherine, Institut du Cancer Avignon Provence
Avignon, , France
EDOG - Institut Bergonie - PPDS
Bordeaux, , France
Universite de Bourgogne - Faculte de Medecine - IN
Dijon, , France
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
Grenoble, , France
Centre Léon Berard
Lyon, , France
EDOG Institut de Cancerologie de l'Ouest - PPDS
Nantes, , France
CHRU de Poitiers La Miletrie
Poitiers, , France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, , France
CHRU de Brest - Hopital Morvan
Saint-Priest-en-Jarez, , France
Hôpital de Rangueil
Toulouse, , France
Hôpital Saint Antoine
Villejuif, , France
Research Institute of Clinical Medicine
Tbilisi, , Georgia
High Technology Hospital MedCenter Ltd
Tbilisi, , Georgia
Institut für Klinisch-Onkologische Forschung
Frankfurt am Main, Hesse, Germany
Attikon University General Hospital
Athens, , Greece
Bioclinic Thessaloniki Oncology Department
Thessaloniki, , Greece
Agios Loucas Clinic SA
Thessaloniki, , Greece
Interbalkan Medical Center of Thessaloniki Oncology Department
Thessaloniki, , Greece
Clinica Medica Especializada CELAN
Guatemala City, , Guatemala
Grupo Medico Angeles
Guatemala City, , Guatemala
Centro Medico Integral de Cancerologia CEMIC
Salcajá, , Guatemala
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, , India
Artemis Hospital
Gūrgaon, , India
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabad, , India
Indraprastha Apollo Hospitals
New Delhi, , India
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, , India
HCG City Cancer Center
Vijayawada, , India
St James's Hospital
Dublin, , Ireland
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, , Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, , Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, , Italy
Istituto Nazionale Dei Tumori
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan, , Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Fondazione Policlinico Universitario A Gemelli
Rome, , Italy
Centro Ricerche Cliniche Di Verona
Verona, , Italy
Azienda ULSS 8 "Berica" - Ospedale San Bortolo
Vicenza, , Italy
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Gifu University Hospital
Gifu, Gihu, Japan
Gunma Prefectural Cancer Center
Ota-shi, Gunma, Japan
Hyogo Cancer Center
Akashi-shi, Hyôgo, Japan
Ibaraki Prefectural Central Hospital
Kasama-Shi, Ibaraki, Japan
Kagawa University Hospital
Kita-Gun Miki-Cho, Kagawa-ken, Japan
Kanagawa Cancer Center
Yokohama-Shi Asahi-Ku, Kanagawa, Japan
Kumamoto University Hospital - Honjo-Kuhonji Campus A
Chuo-Ku, Kumamoto, Japan
Kyoto University Hospital
Sakyo-ku, Kyoto-shi, Japan
Osaki Citizen Hospital
Osaki-Shi, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki-Shi, Okayama-ken, Japan
Osaka University Hospital
Suita-Shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-Shi, Osaka, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
National Cancer Center Hospital
Chūōku, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Saitama Cancer Center
Ina, , Japan
Shikoku Cancer Center
Matsuyama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, , Japan
Hospital Pulau Pinang
George Town, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
National Cancer Institute ( Institut Kanser Negara)
Putrajaya, , Malaysia
Health Pharma Professional Research S.A de C.V.
Mexico City, , Mexico
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, , Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, , Mexico
Catharina Hospital
Eindhoven, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
ETZ-Elisabeth
Tilburg, , Netherlands
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Hospital Garcia de Orta
Almada, , Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
Hospital Senhora da Oliveira - Guimaraes, E.P.E
Guimarães, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos SA
Matosinhos Municipality, , Portugal
Centro Hospitalar do Porto EPE
Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, , Portugal
Fundeni Clinical Institute
Bucharest, , Romania
Prof Dr I Chiricuta Institute of Oncology - PPDS
Cluj-Napoca, , Romania
Medisprof SRL
Cluj-Napoca, , Romania
Oncology Center Sfantul Nectarie
Craiova, , Romania
University Clinical Center of Serbia - PPDS
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Oncology Institute of Vojvodina
Kamenitz, , Serbia
University Clinical Center Nis
Niš, , Serbia
National Cancer Center Singapore
Singapore, , Singapore
Wilgers Oncology Centre
Pretoria, , South Africa
Hallym University Sacred Heart Hospital
Anyang-si, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Institut Català d'Oncologia (Hospital Duran y Reynals)
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Songklanagarind Hospital
Hat Yai, , Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Hacettepe Universitesi Kanser Enstitusu
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Dokuz Eylul Universitesi
Izmir, , Turkey (Türkiye)
Acibadem Adana Hospital
Seyhan, , Turkey (Türkiye)
Medical Park Trabzon Yildizli
Trabzon, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital
Yenimahalle, , Turkey (Türkiye)
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
Lutsk, , Ukraine
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburgh, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, , United Kingdom
Royal Marsden Hospital - London
London, , United Kingdom
Royal Marsden Hospital - Surrey
London, , United Kingdom
Edith Cavell Hospital
Peterborough, , United Kingdom
Weston Park Cancer Centre
Sheffield, , United Kingdom
Countries
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References
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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 1b/2 Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2025 Dec 1. doi: 10.1158/1078-0432.CCR-24-4295. Online ahead of print.
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.
Other Identifiers
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2021-000296-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2061230026
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-510319-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
ZWI-ZW25-301
Identifier Type: -
Identifier Source: org_study_id