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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

920

Participants

Timeline

Start Date

December 2, 2021

Primary Completion Date

December 1, 2025

Study Completion Date

May 15, 2026

Conditions
Gastric NeoplasmsGastroesophageal AdenocarcinomaEsophageal Adenocarcinoma
Interventions
DRUG

Zanidatamab

Administered IV

DRUG

Tislelizumab

Administered IV

DRUG

Trastuzumab

Administered intravenously (IV)

DRUG

Capecitabine

Administered orally (PO bid)

DRUG

Oxaliplatin

Administered IV

DRUG

Cisplatin

Administered IV

DRUG

5-Fluorouracil

Administered IV

Trial Locations (226)

8

St James's Hospital, Dublin

1200

Cliniques Universitaires Saint-Luc, Brussels

1264

Hospital de Gastroenterología Dr Bonorino Udaondo, Buenos Aires

2170

Liverpool Hospital, Liverpool

2700

Centro de Investigación Pergamino S.A., Pergamino

2820

Imelda VZW, Bonheiden

3000

UZ Leuven, Leuven

3084

Austin Health, Heidelberg

4000

CHU de Liège, Liège

5042

Flinders Medical Centre, Bedford Park

6000

High Technology Hospital MedCenter Ltd, Tbilisi

6150

Fiona Stanley Hospital, Murdoch

8915

Hospital Universitario Germans Trias i Pujol, Badalona

9000

UZ Gent, Ghent

10060

Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo

10408

National Cancer Center, Goyang-si

10990

Hospital Pulau Pinang, George Town

11000

University Clinical Center of Serbia - PPDS, Belgrade

11070

Clinical Hospital Center Bezanijska Kosa, Belgrade

11217

Taipei Veterans General Hospital, Taipei

13419

North Estonia Medical Centre Foundation, Tallinn

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14068

Hallym University Sacred Heart Hospital, Anyang-si

16132

Ospedale Policlinico San Martino, Genova

17007

Hospital Universitari de Girona Dr Josep Trueta, Girona

18000

University Clinical Center Nis, Niš

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20133

Istituto Nazionale Dei Tumori, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda, Milan

21079

Universite de Bourgogne - Faculte de Medecine - IN, Dijon

21204

Oncology Institute of Vojvodina, Kamenitz

21565

Gachon University Gil Medical Center, Incheon

22030

Trakya University Medical Faculty, Edirne

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

29010

Hospital Regional Universitario de Malaga - Hospital General, Málaga

31008

Complejo Hospitalario de Navarra, Pamplona

32911

Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca

33000

EDOG - Institut Bergonie - PPDS, Bordeaux

33600

CHU de Bordeaux - Hopital Haut Leveque, Pessac

35000

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

35220

Dokuz Eylul Universitesi, Izmir

36100

"Azienda ULSS 8 Berica - Ospedale San Bortolo", Vicenza

37134

Centro Ricerche Cliniche Di Verona, Verona

38043

Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon, Grenoble

39008

Hospital Universitario Marques de Valdecilla, Santander

40000

Srinagarind Hospital, Khon Kaen University, Khon Kaen

40138

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna

41009

Hospital Universitario Virgen Macarena, Seville

41124

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

41404

Kyungpook National University Chilgok Hospital, Daegu

42270

CHRU de Brest - Hopital Morvan, Saint-Priest-en-Jarez

43018

The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council, Lutsk

43100

Arcispedale Santa Maria Nuova, Reggio Emilia

44805

EDOG Institut de Cancerologie de l'Ouest - PPDS, Nantes

47014

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

49201

Dong-A University Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50011

The Fourth Hospital of Hebei Medical University, Shijiazhuang

54622

Bioclinic Thessaloniki Oncology Department, Thessaloniki

57001

Interbalkan Medical Center of Thessaloniki Oncology Department, Thessaloniki

60488

Institut für Klinisch-Onkologische Forschung, Frankfurt am Main

61310

Medical Park Trabzon Yildizli, Trabzon

62675

National Cancer Institute ( Institut Kanser Negara), Putrajaya

64460

Hospital Universitario Dr. Jose Eleuterio González, Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

69008

Centre Léon Berard, Lyon

69437

Hôpital de Rangueil, Toulouse

84000

Sainte-Catherine, Institut du Cancer Avignon Provence, Avignon

86021

CHRU de Poitiers La Miletrie, Poitiers

90110

Songklanagarind Hospital, Hat Yai

93586

Sarawak General Hospital, Kuching

94800

Hôpital Saint Antoine, Villejuif

100020

Beijing Chao-Yang Hospital, Capital Medical University, Beijing

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100142

Beijing Cancer Hospital, Beijing

100191

Peking University Third Hospital, Beijing

101199

Beijing Luhe Hospital, Capital Medical University, Beijing

110076

Indraprastha Apollo Hospitals, New Delhi

110801

Liaoning Cancer Hospital & Institute, Shenyang

122003

Artemis Hospital, Gūrgaon

143099

The Tonghua Central Hospital, Tonghua

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Ruijin hospital Shanghai Jiao Tong University School of Medicine, Shanghai

200032

Fudan University Affiliated Zhongshan Hospital, Shanghai

Fudan University Shanghai Cancer Center, Shanghai

200080

Shanghai General Hospital, Shanghai

200347

Oncology Center Sfantul Nectarie, Craiova

210008

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

213004

Changzhou First People's Hospital, Changzhou

214062

Affiliated Hospital of Jiangnan University, Wuxi

225001

Northern Jiangsu People's Hospital, Yangzhou

230031

Anhui Provincial Cancer Hospital, Hefei

230601

The Second Affiliated Hospital of Anhui Medical University, Hefei

233004

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250000

Shandong Cancer Hospital, Jinan

250013

Jinan Central Hospital, Jinan

258500

National Cancer Center Singapore, Singapore

264200

Weihai Municipal Hospital, Weihai

266003

The Affiliated Hospital of Qingdao University, Qingdao

300041

Tianjin Medical University General Hospital, Tianjin

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310003

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

310016

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

310017

Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

330052

The First Affiliated Hospital of Nanchang University, Nanchang

350005

The First Affiliated Hospital of Fujian Medical University, Fuzhou

350014

Fujian Cancer Hospital, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

400015

Prof Dr I Chiricuta Institute of Oncology - PPDS, Cluj-Napoca

400641

Medisprof SRL, Cluj-Napoca

404472

China Medical University Hospital, Taichung

410031

Hunan Cancer Hospital, Changsha

430023

Union Hospital Tongji Medical College HuaZhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450003

Henan Cancer Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

500004

MNJ Institute of Oncology and Regional Cancer Centre, Hyderabad

510055

Guangdong Provincial People's Hospital, Guangzhou

510655

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

520002

HCG City Cancer Center, Vijayawada

570311

Hainan General Hospital, Haikou

610042

Sichuan Cancer Hospital & Institute, Chengdu

650118

Yunnan Cancer Hospital, Kunming

710061

First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an

730013

The First Hospital of Lanzhou University, Lanzhou

730050

Gansu Cancer Hospital, Lanzhou

751019

All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar

800014

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences, Patna

830026

Cancer Hospital affiliated to Xinjiang Medical University, Ürümqi

4810469

Sociedad de Investigaciones Medicas Limitada, Temuco

7500000

Fundación Arturo López Pérez (FALP) - PPDS, Providencia

Centro de Estudios Clínicos SAGA SpA, Providencia

Sociedad Oncovida S.A, Santiago

8150513

Icegclinic, Santiago

8330336

BIOCINETIC SpA, Santiago

8420383

Centro Internacional de Estudios Clinicos CIEC, Santiago

C1012

Instituto de Investigaciones Metabólicas - IDIM, Buenos Aires

C1181ACH

Hospital Italiano de Buenos Aires, Buenos Aires

X5000HXL

Fundación Centro de Medicina Nuclear y Molecular ER, Córdoba

X5008HHW

Centro Médico Privado CEMAIC, Córdoba

R8500ACE

Centro de Investigación Clínica - Clínica Viedma, Viedma

14784-400

Centro Integrado de Pesquisa - CIP, Barretos

Fundação Pio XII Hospital de Câncer de Barretos, Barretos

30130-090

Cenantron - Centro Avancado de Tratamento Oncologico Ltda, Belo Horizonte

70840-901

Centro de Pesquisas Clínicas/Fundação Doutor Amaral Carvalho, Brasília

60430-230

Instituto Do Câncer Do Ceará ICC, Fortaleza

90050-170

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

Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

91350-200

Hospital Nossa Senhora Da Conceição, Porto Alegre

09060-650

Núcleo de Pesquisa Clínica da Rede São Camilo, Santo André

01246-000

Instituto do Cancer do Estado de São Paulo ICESP, São Paulo

18030-075

Instituto de Oncologia de Sorocaba, Sorocaba

M5G 2C1

Princess Margaret Cancer Centre, Toronto

046099

Changzhi People's Hospital, Changzhi

01000

Affiliated Hospital of Inner Mongolia Medical University, Hohhot

0112

Research Institute of Clinical Medicine, Tbilisi

124 64

Attikon University General Hospital, Athens

552 36

Agios Loucas Clinic SA, Thessaloniki

01010

Clinica Medica Especializada CELAN, Guatemala City

01015

Grupo Medico Angeles, Guatemala City

09002

Centro Medico Integral de Cancerologia CEMIC, Salcajá

00168

Fondazione Policlinico Universitario A Gemelli, Rome

260-0801

Chiba Cancer Center, Chiba

277-8577

National Cancer Center Hospital East, Kashiwa-shi

501-1112

Gifu University Hospital, Gifu

373-8550

Gunma Prefectural Cancer Center, Ota-shi

673-8558

Hyogo Cancer Center, Akashi-shi

309-1793

Ibaraki Prefectural Central Hospital, Kasama-Shi

761-0701

Kagawa University Hospital, Kita-Gun Miki-Cho

241-0815

Kanagawa Cancer Center, Yokohama-Shi Asahi-Ku

860-8556

Kumamoto University Hospital - Honjo-Kuhonji Campus A, Chuo-Ku

606-8507

Kyoto University Hospital, Sakyo-ku

989-6136

Osaki Citizen Hospital, Osaki-Shi

710-0052

Kurashiki Central Hospital, Kurashiki-Shi

565-0871

Osaka University Hospital, Suita-Shi

569-8686

Osaka Medical and Pharmaceutical University Hospital, Takatsuki-Shi

160-8582

Keio University Hospital, Shinjuku-Ku

104-0045

National Cancer Center Hospital, Chūōku

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

362-0806

Saitama Cancer Center, Ina

791-0245

Shikoku Cancer Center, Matsuyama

540-0008

Osaka International Cancer Institute, Osaka

589-0014

Kindai University Hospital, Ōsaka-sayama

135-8550

The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Tokyo

03100

Health Pharma Professional Research S.A de C.V., Mexico City

5623 EJ

Catharina Hospital, Eindhoven

2333 ZA

Leids Universitair Medisch Centrum, Leiden

5042 AD

ETZ-Elisabeth, Tilburg

93-513

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

02-034

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warsaw

2801-951

Hospital Garcia de Orta, Almada

3000-459

Centro Hospitalar E Universitário de Coimbra EPE, Coimbra

4830-044

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

1649-035

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

4454-509

Unidade Local de Saúde de Matosinhos SA, Matosinhos Municipality

4099-001

Centro Hospitalar do Porto EPE, Porto

4200-072

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

022328

Fundeni Clinical Institute, Bucharest

0184

Wilgers Oncology Centre, Pretoria

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

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

03181

Kangbuk Samsung Hospital, Seoul

03686

Severance Hospital Yonsei University Health System - PPDS, Seoul

05505

Asan Medical Center, Seoul

06229

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

08908

Institut Català d'Oncologia (Hospital Duran y Reynals), L'Hospitalet de Llobregat

06230

Hacettepe Universitesi Kanser Enstitusu, Ankara

01130

Acibadem Adana Hospital, Seyhan

06200

Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital, Yenimahalle

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

EH4 2XU

Western General Hospital Edinburgh - PPDS, Edinburgh

LS9 7TF

St James University Hospital, Leeds

SE1 9RT

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

SW7 3RP

Royal Marsden Hospital - London, London

Royal Marsden Hospital - Surrey, London

PE3 9GZ

Edith Cavell Hospital, Peterborough

S10 2SJ

Weston Park Cancer Centre, Sheffield

All Listed Sponsors
collaborator

BeOne Medicines LTD

UNKNOWN

collaborator

BeOne Pharmaceutical Co., Ltd.

UNKNOWN

lead

Jazz Pharmaceuticals

INDUSTRY