AzTrials
AzTrials

Gastric NeoplasmsPhase 3HERIZON-GEA-01NCT05152147

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

A Phase 3 study testing Zanidatamab, Tislelizumab and Trastuzumab in people with Gastric Neoplasms and Gastroesophageal Adenocarcinoma, run by Jazz Pharmaceuticals at 227 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zanidatamab, Tislelizumab and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
920 participants
Where
227 sitesin 33 countries
Study dates
2 Dec 2021to 30 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

227 sites in 33 countries.

227 sites in 33 countries

China51 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, 100020

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, 101199

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • Hunan Cancer Hospital

    Changsha, 410031

  • Changzhi People's Hospital

    Changzhi, 046099

  • Changzhou First People's Hospital

    Changzhou, 213004

  • Sichuan Cancer Hospital & Institute

    Chengdu, 610042

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Guangdong Provincial People's Hospital

    Guangzhou, 510055

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655

  • Hainan General Hospital

    Haikou, 570311

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310017

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 01000

  • Shandong Cancer Hospital

    Jinan, 250000

  • Jinan Central Hospital

    Jinan, 250013

  • Yunnan Cancer Hospital

    Kunming, 650118

  • The First Hospital of Lanzhou University

    Lanzhou, 730013

  • Gansu Cancer Hospital

    Lanzhou, 730050

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330052

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

    Nanjing, 210008

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003

  • Ruijin hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Fudan University Affiliated Zhongshan Hospital

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai General Hospital

    Shanghai, 200080

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110801

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, 50011

  • Tianjin Medical University General Hospital

    Tianjin, 300041

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • The Tonghua Central Hospital

    Tonghua, 143099

  • Cancer Hospital affiliated to Xinjiang Medical University

    Ürümqi, 830026

  • Weihai Municipal Hospital

    Weihai, 264200

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Union Hospital Tongji Medical College HuaZhong University of Science and Technology

    Wuhan, 430023

  • Hubei Cancer Hospital

    Wuhan, 430079

  • Affiliated Hospital of Jiangnan University

    Wuxi, 214062

  • First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Northern Jiangsu People's Hospital

    Yangzhou, 225001

  • Henan Cancer Hospital

    Zhengzhou, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Japan22 sites

  • Hyogo Cancer Center

    Akashi-shi, Hyôgo, 673-8558

  • Chiba Cancer Center

    Chiba, Chiba, 260-0801

  • Kumamoto University Hospital - Honjo-Kuhonji Campus A

    Chuo-Ku, Kumamoto, 860-8556

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Gifu University Hospital

    Gifu, Gihu, 501-1112

  • Saitama Cancer Center

    Ina, 362-0806

  • Ibaraki Prefectural Central Hospital

    Kasama-Shi, Ibaraki, 309-1793

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Kagawa University Hospital

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

  • Kurashiki Central Hospital

    Kurashiki-Shi, Okayama-ken, 710-0052

  • Shikoku Cancer Center

    Matsuyama, 791-0245

  • Osaka International Cancer Institute

    Osaka, 540-0008

  • Kindai University Hospital

    Ōsaka-sayama, 589-0014

  • Osaki Citizen Hospital

    Osaki-Shi, Miyagi, 989-6136

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, 373-8550

  • Kyoto University Hospital

    Sakyo-ku, Kyoto-shi, 606-8507

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-Shi, Osaka, 569-8686

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Tokyo, 135-8550

  • Kanagawa Cancer Center

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

Other trials in Japan

South Korea16 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

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

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03686

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06229

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Spain13 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 8915

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Institut Català d'Oncologia (Hospital Duran y Reynals)

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 32911

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France12 sites

  • Sainte-Catherine, Institut du Cancer Avignon Provence

    Avignon, 84000

  • EDOG - Institut Bergonie - PPDS

    Bordeaux, 33000

  • Universite de Bourgogne - Faculte de Medecine - IN

    Dijon, 21079

  • Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

    Grenoble, 38043

  • Centre Léon Berard

    Lyon, 69008

  • EDOG Institut de Cancerologie de l'Ouest - PPDS

    Nantes, 44805

  • CHU de Bordeaux - Hopital Haut Leveque

    Pessac, Gironde, 33600

  • CHRU de Poitiers La Miletrie

    Poitiers, 86021

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

    Rennes, 35000

  • CHRU de Brest - Hopital Morvan

    Saint-Priest-en-Jarez, 42270

  • Hôpital de Rangueil

    Toulouse, 69437

  • Hôpital Saint Antoine

    Villejuif, 94800

Other trials in France

Italy12 sites

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, 40138

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    Candiolo, 10060

  • Ospedale Policlinico San Martino

    Genova, 16132

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

    Meldola, 47014

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, 20132

  • Istituto Nazionale Dei Tumori

    Milan, 20133

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

    Milan, 20162

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, 41124

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 43100

  • Fondazione Policlinico Universitario A Gemelli

    Rome, 00168

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134

  • Azienda ULSS 8 "Berica" - Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Brazil11 sites

  • Centro Integrado de Pesquisa - CIP

    Barretos, 14784-400

  • Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, 14784-400

  • Cenantron - Centro Avancado de Tratamento Oncologico Ltda

    Belo Horizonte, 30130-090

  • Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho

    Brasília, 70840-901

  • Instituto Do Câncer Do Ceará ICC

    Fortaleza, 60430-230

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, 90050-170

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital Nossa Senhora Da Conceição

    Porto Alegre, 91350-200

  • Núcleo de Pesquisa Clínica da Rede São Camilo

    Santo André, 09060-650

  • Instituto do Cancer do Estado de São Paulo ICESP

    São Paulo, 01246-000

  • Instituto de Oncologia de Sorocaba

    Sorocaba, 18030-075

Other trials in Brazil

United Kingdom8 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Western General Hospital Edinburgh - PPDS

    Edinburgh, EH4 2XU

  • St James University Hospital

    Leeds, LS9 7TF

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

    London, SE1 9RT

  • Royal Marsden Hospital - London

    London, SW7 3RP

  • Royal Marsden Hospital - Surrey

    London, SW7 3RP

  • Edith Cavell Hospital

    Peterborough, PE3 9GZ

  • Weston Park Cancer Centre

    Sheffield, S10 2SJ

Other trials in United Kingdom

Argentina7 sites

  • Hospital de Gastroenterología Dr Bonorino Udaondo

    Buenos Aires, 1264

  • Instituto de Investigaciones Metabólicas - IDIM

    Buenos Aires, C1012

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Fundación Centro de Medicina Nuclear y Molecular ER

    Córdoba, X5000HXL

  • Centro Médico Privado CEMAIC

    Córdoba, X5008HHW

  • Centro de Investigación Pergamino S.A.

    Pergamino, 2700

  • Centro de Investigación Clínica - Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Chile7 sites

  • Fundación Arturo López Pérez (FALP) - PPDS

    Providencia, Santiago Metropolitan, 7500000

  • Centro de Estudios Clínicos SAGA SpA

    Providencia, 7500000

  • Centro Internacional de Estudios Clinicos CIEC

    Santiago, Region Metropolitan, 8420383

  • Sociedad Oncovida S.A

    Santiago, 7500000

  • Icegclinic

    Santiago, 8150513

  • BIOCINETIC SpA

    Santiago, 8330336

  • Sociedad de Investigaciones Medicas Limitada

    Temuco, 4810469

Other trials in Chile

Portugal7 sites

  • Hospital Garcia de Orta

    Almada, 2801-951

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-459

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

    Guimarães, 4830-044

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

    Lisbon, 1649-035

  • Unidade Local de Saúde de Matosinhos SA

    Matosinhos Municipality, 4454-509

  • Centro Hospitalar do Porto EPE

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072

Other trials in Portugal

India6 sites

  • All India Institute of Medical Sciences, Bhubaneswar

    Bhubaneswar, 751019

  • Artemis Hospital

    Gūrgaon, 122003

  • MNJ Institute of Oncology and Regional Cancer Centre

    Hyderabad, 500004

  • Indraprastha Apollo Hospitals

    New Delhi, 110076

  • Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

    Patna, 800014

  • HCG City Cancer Center

    Vijayawada, 520002

Other trials in India

Turkey (Türkiye)6 sites

  • Hacettepe Universitesi Kanser Enstitusu

    Ankara, 06230

  • Trakya University Medical Faculty

    Edirne, 22030

  • Dokuz Eylul Universitesi

    Izmir, 35220

  • Acibadem Adana Hospital

    Seyhan, 01130

  • Medical Park Trabzon Yildizli

    Trabzon, 61310

  • Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital

    Yenimahalle, 06200

Other trials in Turkey (Türkiye)

Belgium5 sites

  • Imelda VZW

    Bonheiden, 2820

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

Australia4 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Austin Health

    Heidelberg, 3084

  • Liverpool Hospital

    Liverpool, 2170

  • Fiona Stanley Hospital

    Murdoch, 6150

Other trials in Australia

Greece4 sites

  • Attikon University General Hospital

    Athens, 124 64

  • Bioclinic Thessaloniki Oncology Department

    Thessaloniki, 54622

  • Agios Loucas Clinic SA

    Thessaloniki, 552 36

  • Interbalkan Medical Center of Thessaloniki Oncology Department

    Thessaloniki, 57001

Other trials in Greece

Romania4 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Prof Dr I Chiricuta Institute of Oncology - PPDS

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400641

  • Oncology Center Sfantul Nectarie

    Craiova, 200347

Other trials in Romania

Serbia4 sites

  • University Clinical Center of Serbia - PPDS

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11070

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • University Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Guatemala3 sites

  • Clinica Medica Especializada CELAN

    Guatemala City, 01010

  • Grupo Medico Angeles

    Guatemala City, 01015

  • Centro Medico Integral de Cancerologia CEMIC

    Salcajá, 09002

Other trials in Guatemala

Malaysia3 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Sarawak General Hospital

    Kuching, 93586

  • National Cancer Institute ( Institut Kanser Negara)

    Putrajaya, 62675

Other trials in Malaysia

Mexico3 sites

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

    Mexico City, 03100

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey, 64460

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

Other trials in Mexico

Netherlands3 sites

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • ETZ-Elisabeth

    Tilburg, 5042 AD

Other trials in Netherlands

Thailand3 sites

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40000

  • Chulaborn Hospital

    Lak Si, 10210

Other trials in Thailand

Georgia2 sites

  • Research Institute of Clinical Medicine

    Tbilisi, 0112

  • High Technology Hospital MedCenter Ltd

    Tbilisi, 6000

Other trials in Georgia

Poland2 sites

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

    Lodz, 93-513

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-034

Other trials in Poland

Taiwan2 sites

  • China Medical University Hospital

    Taichung, 404472

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, M5G 2C1

Other trials in Canada

Estonia1 site

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

Germany1 site

  • Institut für Klinisch-Onkologische Forschung

    Frankfurt am Main, Hesse, 60488

Other trials in Germany

Ireland1 site

  • St James's Hospital

    Dublin, 8

Other trials in Ireland

Singapore1 site

  • National Cancer Center Singapore

    Singapore, 258500

Other trials in Singapore

South Africa1 site

  • Wilgers Oncology Centre

    Pretoria, 0184

Other trials in South Africa

Ukraine1 site

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

    Dnipropetrovsk, 49102

Other trials in Ukraine

About this study

Official title: 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).

Being tested
Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
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
Medical subject headings
Stomach Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05152147
Study groupRoleWhat they receive
Arm AActive comparatorTrastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil
Arm BExperimentalZanidatamab plus physician's choice of CAPOX or FP
Receives: Drug: Zanidatamab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil
Arm CExperimentalZanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Receives: Drug: Zanidatamab; Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Cisplatin; Drug: 5-Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 2.5 years

  2. Overall survival

    The time from randomization to death due to any cause

    Measured: Up to 3.5 years

Secondary outcomes (14)

  1. Confirmed objective response rate (ORR) by BICR

    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

    Measured: Up to 2.5 years

  2. Duration of response (DOR) by BICR

    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

    Measured: Up to 2.5 years

  3. PFS per Investigator assessment

    The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause

    Measured: Up to 2.5 years

  4. Confirmed ORR per Investigator assessment

    Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator

    Measured: Up to 2.5 years

  5. DOR per Investigator assessment

    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

    Measured: Up to 2.5 years

  6. Assessment of Contribution of Components based on 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

    Measured: Up to 2.5 years

  7. Assessment of Contribution of Components based on Overall Survival

    The time from randomization to death due to any cause

    Measured: Up to 3.5 years

  8. Incidence of adverse events

    Number of subjects who experienced adverse events or serious adverse events

    Measured: Up to 2 years

  9. Incidence of clinical laboratory abnormalities

    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

    Measured: Up to 2 years

  10. 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)

    Changes from baseline in the EORTC QLQ-C30 scores

    Measured: Up to 2.5 years

  11. HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)

    Changes from baseline in the EORTC QLQ-OG25 scores

    Measured: Up to 2.5 years

  12. HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire

    Changes from baseline in the EORTC EQ-5D-5L questionnaire scores

    Measured: Up to 2.5 years

  13. Serum concentration of zanidatamab and tislelizumab

    Measured: Up to 2 years

  14. Incidence of anti-drug antibodies (ADAs)

    Number of patients who develop ADAs

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start2 Dec 2021
  3. Primary completion15 Jul 2026
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multi-cohort, open-label, multicenter study
Masking
None (open label)
Enrolment
920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05152147
Sponsor's protocol ID
ZWI-ZW25-301
Other IDs
2021-000296-36, jRCT2061230026, 2023-510319-20-00, 2023
Acronym
HERIZON-GEA-01
Status last verified
Oct 2026
First submitted
5 Nov 2021
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Expanded access
Available

Publications

  • Shitara K, Elimova E, Liu T, Tabernero J, Lee KW, Schenker M, Tebbutt NC, Ajani J, Salimin N, Ku G, Gwang Kim J, Ales Diaz I, Zhang J, Pietrantonio F, Bai LY, Le Sourd S, Zhao J, Hierro C, Kiberu A, Van Herpe F, Bao Y, Zhang H, Yang L, Li V, Gartner EM, Chen Y, Grim J, Rha SY, Shen L; HERIZON-GEA-01 Investigators. Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer. N Engl J Med. 2026 May 28;394(20):2002-2014. doi: 10.1056/NEJMoa2517729.

    PubMed 42202319

  • 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.

    PubMed 41324998

  • 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.

    PubMed 40341124

  • 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.

    PubMed 36000541

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zanidatamab, Tislelizumab and Trastuzumab in people with Gastric Neoplasms and Gastroesophageal Adenocarcinoma, run by Jazz Pharmaceuticals at 227 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in China, Japan, South Korea, Spain, France and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) by BICR (time frame: Up to 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05152147, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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