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

NCT05152147 | Active Not Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: ZWI-ZW25-3012021-000296-36jRCT20612300262023-510319-20-00
• Study Type: interventional
• Target: 920
• Locations: 32 countries
• Sites: 226

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).

Conditions

Gastric Neoplasms; Esophageal Adenocarcinoma; Gastroesophageal Adenocarcinoma

Keywords

HER2; Bispecific antibody; Biparatopic antibody; Immunotherapy; Gastric cancers; Esophageal cancers; Chemotherapy; FP; Capecitabine; Cisplatin; 5-FU; Oxaliplatin; Gastroesophageal adenocarcinoma; CAPOX; Programmed cell death receptor 1 (PD-1); Anti-PD-1; Anti PD-1; JZP598

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS) by BICR

  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

• Overall survival

  The time from randomization to death due to any cause

  Up to 3.5 years

Secondary Outcomes (14)

• Confirmed objective response rate (ORR) by BICR

  Up to 2.5 years

• Duration of response (DOR) by BICR

  Up to 2.5 years

• PFS per Investigator assessment

  Up to 2.5 years

• Confirmed ORR per Investigator assessment

  Up to 2.5 years

• DOR per Investigator assessment

  Up to 2.5 years

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)

Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil

Arm B

EXPERIMENTAL

Zanidatamab plus physician's choice of CAPOX or FP

Drug: Zanidatamab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil

Arm C

EXPERIMENTAL

Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP

Drug: Zanidatamab; Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil

Interventions

Zanidatamab DRUG

Administered IV

Also known as: ZW25, JZP598, ZIIHERA®

Arm B; Arm C

Tislelizumab DRUG

Administered IV

Arm C

Capecitabine DRUG

Administered orally (PO bid)

Arm A; Arm B; Arm C

Oxaliplatin DRUG

Administered IV

Arm A; Arm B; Arm C

Cisplatin DRUG

Administered IV

Arm A; Arm B; Arm C

5-Fluorouracil DRUG

Administered IV

Arm A; Arm B; Arm C

Trastuzumab DRUG

Administered intravenously (IV)

Also known as: Herceptin®

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• BeOne Medicines LTD: collaborator
• Jazz Pharmaceuticals: lead
• BeOne Pharmaceutical Co., Ltd.: collaborator

Study Sites (227)

Hospital de Gastroenterología Dr Bonorino Udaondo

Buenos Aires, 1264, Argentina

Location

Instituto de Investigaciones Metabólicas - IDIM

Buenos Aires, C1012, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Fundación Centro de Medicina Nuclear y Molecular ER

Córdoba, X5000HXL, Argentina

Location

Centro Médico Privado CEMAIC

Córdoba, X5008HHW, Argentina

Location

Centro de Investigación Pergamino S.A.

Pergamino, 2700, Argentina

Location

Centro de Investigación Clínica - Clínica Viedma

Viedma, R8500ACE, Argentina

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

Austin Health

Heidelberg, 3084, Australia

Location

Liverpool Hospital

Liverpool, 2170, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Imelda VZW

Bonheiden, 2820, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Centro Integrado de Pesquisa - CIP

Barretos, 14784-400, Brazil

Location

Fundação Pio XII Hospital de Câncer de Barretos

Barretos, 14784-400, Brazil

Location

Cenantron - Centro Avancado de Tratamento Oncologico Ltda

Belo Horizonte, 30130-090, Brazil

Location

Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho

Brasília, 70840-901, Brazil

Location

Instituto Do Câncer Do Ceará ICC

Fortaleza, 60430-230, Brazil

Location

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, 90050-170, Brazil

Location

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90050-170, Brazil

Location

Hospital Nossa Senhora Da Conceição

Porto Alegre, 91350-200, Brazil

Location

Núcleo de Pesquisa Clínica da Rede São Camilo

Santo André, 09060-650, Brazil

Location

Instituto do Cancer do Estado de São Paulo ICESP

São Paulo, 01246-000, Brazil

Location

Instituto de Oncologia de Sorocaba

Sorocaba, 18030-075, Brazil

Location

Princess Margaret Cancer Centre

Toronto, M5G 2C1, Canada

Location

Centro Internacional de Estudios Clinicos CIEC

Santiago, Region Metropolitan, 8420383, Chile

Location

Fundación Arturo López Pérez (FALP) - PPDS

Providencia, Santiago Metropolitan, 7500000, Chile

Location

Centro de Estudios Clínicos SAGA SpA

Providencia, 7500000, Chile

Location

Sociedad Oncovida S.A

Santiago, 7500000, Chile

Location

Icegclinic

Santiago, 8150513, Chile

Location

BIOCINETIC SpA

Santiago, 8330336, Chile

Location

Sociedad de Investigaciones Medicas Limitada

Temuco, 4810469, Chile

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, 100020, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, 101199, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, 233004, China

Location

Hunan Cancer Hospital

Changsha, 410031, China

Location

Changzhi People's Hospital

Changzhi, 046099, China

Location

Changzhou First People's Hospital

Changzhou, 213004, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, 610042, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510055, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510655, China

Location

Hainan General Hospital

Haikou, 570311, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, 310003, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310017, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Anhui Provincial Cancer Hospital

Hefei, 230031, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, 230601, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, 01000, China

Location

Shandong Cancer Hospital

Jinan, 250000, China

Location

Jinan Central Hospital

Jinan, 250013, China

Location

Yunnan Cancer Hospital

Kunming, 650118, China

Location

The First Hospital of Lanzhou University

Lanzhou, 730013, China

Location

Gansu Cancer Hospital

Lanzhou, 730050, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, 330052, China

Location

Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School

Nanjing, 210008, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

Location

Ruijin hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

Fudan University Affiliated Zhongshan Hospital

Shanghai, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanghai General Hospital

Shanghai, 200080, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, 110801, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, 50011, China

Location

Tianjin Medical University General Hospital

Tianjin, 300041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

Location

The Tonghua Central Hospital

Tonghua, 143099, China

Location

Cancer Hospital affiliated to Xinjiang Medical University

Ürümqi, 830026, China

Location

Weihai Municipal Hospital

Weihai, 264200, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

Union Hospital Tongji Medical College HuaZhong University of Science and Technology

Wuhan, 430023, China

Location

Hubei Cancer Hospital

Wuhan, 430079, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, 214062, China

Location

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, 710061, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, 361003, China

Location

Northern Jiangsu People's Hospital

Yangzhou, 225001, China

Location

Henan Cancer Hospital

Zhengzhou, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

CHU de Bordeaux - Hopital Haut Leveque

Pessac, Gironde, 33600, France

Location

Sainte-Catherine, Institut du Cancer Avignon Provence

Avignon, 84000, France

Location

EDOG - Institut Bergonie - PPDS

Bordeaux, 33000, France

Location

Universite de Bourgogne - Faculte de Medecine - IN

Dijon, 21079, France

Location

Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

Grenoble, 38043, France

Location

Centre Léon Berard

Lyon, 69008, France

Location

EDOG Institut de Cancerologie de l'Ouest - PPDS

Nantes, 44805, France

Location

CHRU de Poitiers La Miletrie

Poitiers, 86021, France

Location

EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

Rennes, 35000, France

Location

CHRU de Brest - Hopital Morvan

Saint-Priest-en-Jarez, 42270, France

Location

Hôpital de Rangueil

Toulouse, 69437, France

Location

Hôpital Saint Antoine

Villejuif, 94800, France

Location

Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

High Technology Hospital MedCenter Ltd

Tbilisi, 6000, Georgia

Location

Institut für Klinisch-Onkologische Forschung

Frankfurt am Main, Hesse, 60488, Germany

Location

Attikon University General Hospital

Athens, 124 64, Greece

Location

Bioclinic Thessaloniki Oncology Department

Thessaloniki, 54622, Greece

Location

Agios Loucas Clinic SA

Thessaloniki, 552 36, Greece

Location

Interbalkan Medical Center of Thessaloniki Oncology Department

Thessaloniki, 57001, Greece

Location

Clinica Medica Especializada CELAN

Guatemala City, 01010, Guatemala

Location

Grupo Medico Angeles

Guatemala City, 01015, Guatemala

Location

Centro Medico Integral de Cancerologia CEMIC

Salcajá, 09002, Guatemala

Location

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, 751019, India

Location

Artemis Hospital

Gurgaon, 122003, India

Location

MNJ Institute of Oncology and Regional Cancer Centre

Hyderabad, 500004, India

Location

Indraprastha Apollo Hospitals

New Delhi, 110076, India

Location

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

Patna, 800014, India

Location

HCG City Cancer Center

Vijayawada, 520002, India

Location

St James's Hospital

Dublin, 8, Ireland

Location

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, 40138, Italy

Location

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, 10060, Italy

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

Meldola, 47014, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, 20132, Italy

Location

Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, 20162, Italy

Location

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, 41124, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 43100, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Rome, 00168, Italy

Location

Centro Ricerche Cliniche Di Verona

Verona, 37134, Italy

Location

Azienda ULSS 8 "Berica" - Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Chiba Cancer Center

Chiba, Chiba, 260-0801, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Gifu University Hospital

Gifu, Gihu, 501-1112, Japan

Location

Gunma Prefectural Cancer Center

Ota-shi, Gunma, 373-8550, Japan

Location

Hyogo Cancer Center

Akashi-shi, Hyôgo, 673-8558, Japan

Location

Ibaraki Prefectural Central Hospital

Kasama-Shi, Ibaraki, 309-1793, Japan

Location

Kagawa University Hospital

Kita-Gun Miki-Cho, Kagawa-ken, 761-0701, Japan

Location

Kanagawa Cancer Center

Yokohama-Shi Asahi-Ku, Kanagawa, 241-0815, Japan

Location

Kumamoto University Hospital - Honjo-Kuhonji Campus A

Chuo-Ku, Kumamoto, 860-8556, Japan

Location

Kyoto University Hospital

Sakyo-ku, Kyoto-shi, 606-8507, Japan

Location

Osaki Citizen Hospital

Osaki-Shi, Miyagi, 989-6136, Japan

Location

Kurashiki Central Hospital

Kurashiki-Shi, Okayama-ken, 710-0052, Japan

Location

Osaka University Hospital

Suita-Shi, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-Shi, Osaka, 569-8686, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

National Cancer Center Hospital

Chūōku, 104-0045, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Saitama Cancer Center

Ina, 362-0806, Japan

Location

Shikoku Cancer Center

Matsuyama, 791-0245, Japan

Location

Osaka International Cancer Institute

Osaka, 540-0008, Japan

Location

Kindai University Hospital

Ōsaka-sayama, 589-0014, Japan

Location

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, 135-8550, Japan

Location

Hospital Pulau Pinang

George Town, 10990, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

National Cancer Institute ( Institut Kanser Negara)

Putrajaya, 62675, Malaysia

Location

Health Pharma Professional Research S.A de C.V.

Mexico City, 03100, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, 64460, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020, Mexico

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

Location

ETZ-Elisabeth

Tilburg, 5042 AD, Netherlands

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, 93-513, Poland

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-034, Poland

Location

Hospital Garcia de Orta

Almada, 2801-951, Portugal

Location

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, 3000-459, Portugal

Location

Hospital Senhora da Oliveira - Guimaraes, E.P.E

Guimarães, 4830-044, Portugal

Location

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Unidade Local de Saúde de Matosinhos SA

Matosinhos Municipality, 4454-509, Portugal

Location

Centro Hospitalar do Porto EPE

Porto, 4099-001, Portugal

Location

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

Porto, 4200-072, Portugal

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

Prof Dr I Chiricuta Institute of Oncology - PPDS

Cluj-Napoca, 400015, Romania

Location

Medisprof SRL

Cluj-Napoca, 400641, Romania

Location

Oncology Center Sfantul Nectarie

Craiova, 200347, Romania

Location

University Clinical Center of Serbia - PPDS

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11070, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

University Clinical Center Nis

Niš, 18000, Serbia

Location

National Cancer Center Singapore

Singapore, 258500, Singapore

Location

Wilgers Oncology Centre

Pretoria, 0184, South Africa

Location

Hallym University Sacred Heart Hospital

Anyang-si, 14068, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03686, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06229, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, 8915, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Institut Català d'Oncologia (Hospital Duran y Reynals)

L'Hospitalet de Llobregat, 08908, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga - Hospital General

Málaga, 29010, Spain

Location

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 32911, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

China Medical University Hospital

Taichung, 404472, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Songklanagarind Hospital

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, 40000, Thailand

Location

Chulaborn Hospital

Lak Si, 10210, Thailand

Location

Hacettepe Universitesi Kanser Enstitusu

Ankara, 06230, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi

Izmir, 35220, Turkey (Türkiye)

Location

Acibadem Adana Hospital

Seyhan, 01130, Turkey (Türkiye)

Location

Medical Park Trabzon Yildizli

Trabzon, 61310, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital

Yenimahalle, 06200, Turkey (Türkiye)

Location

Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

Dnipropetrovsk, 49102, Ukraine

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Western General Hospital Edinburgh - PPDS

Edinburgh, EH4 2XU, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Royal Marsden Hospital - London

London, SW7 3RP, United Kingdom

Location

Royal Marsden Hospital - Surrey

London, SW7 3RP, United Kingdom

Location

Edith Cavell Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Weston Park Cancer Centre

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 41324998 DERIVED

• 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.

  PMID: 40341124 DERIVED

• 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.

  PMID: 36000541 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

zanidatamab; tislelizumab; Trastuzumab; Capecitabine; Oxaliplatin; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: multi-cohort, open-label, multicenter study

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 9, 2021
• Study Start: December 2, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16); TW (2); GU (3); AR (7); UA (1); NL (3); CN (51); ZA (1); GR (4); GB (8); AU (4); CA (1); BR (11); FR (12); IE (1); RO (4); TH (3); ES (13); PT (7); JP (22); TU (6); DE (1); IN (6); IT (12); PL (2); GE (2); CL (7); SE (4); SG (1); MY (3); ME (3); BE (5)