AzTrials
AzTrials

Biliary Tract CancerPhase 3NCT06282575

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

A Phase 3 study testing Zanidatamab, Cisplatin and Gemcitabine in people with Biliary Tract Cancer, run by Jazz Pharmaceuticals at 185 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Zanidatamab, Cisplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
185 sitesin 25 countries
Study dates
19 Jul 2024to 1 Apr 2030
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- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
  • Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
  • Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
  • HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
  • Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
  • Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function
  • Females of childbearing potential must have a negative pregnancy test result.
  • Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Who cannot join

  • Prior treatment with a HER2-targeted agent
  • Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
  • The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
  • Use of systemic corticosteroids.
  • Brain metastases
  • Severe chronic or active infections
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  • History of allogeneic organ transplantation.
  • Active or prior autoimmune inflammatory conditions
  • History of interstitial lung disease or non-infectious pneumonitis.
  • Participation in another clinical trial with an investigational medicinal product within the last 3 months.
  • Females who are breastfeeding
  • Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
  • Use of phenytoin

Trial locations and contacts

185 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

185 sites in 25 countries

United States21 sites, 3 recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

    Completed

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Completed

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Withdrawn

  • Texas Oncology - DFW

    Dallas, Texas, 75246

    Withdrawn

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Active, not recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Withdrawn

  • City of Hope(City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

    Active, not recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Withdrawn

  • The Univerrsity of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Active, not recruiting

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree, Colorado, 80124

    Withdrawn

  • Norton Cancer Institute - Audubon

    Louisville, Kentucky, 40217

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota, 55369

    Withdrawn

  • Atlantic Health System/Morristown Medical Center

    Morristown, New Jersey, 07960

    Withdrawn

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Withdrawn

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center

    New York, New York, 10016

    Completed

  • Memorial Sloan Kettering Cancer Centers

    New York, New York, 10022

    Active, not recruiting

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Virginia Commonwealth University, VCU Health

    Richmond, Virginia, 23219

    Active, not recruiting

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

    Withdrawn

Other trials in United States

Japan20 sites, 11 recruiting

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

    Recruiting

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

    Recruiting

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

    Active, not recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

    Completed

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

    Active, not recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 9208641

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

    Recruiting

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Koto-Ku, Tokyo, 135-8550

    Recruiting

  • Kyoto University Hospital

    Kyoto, Kyôto, 606-8507

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Active, not recruiting

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

    Recruiting

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

    Active, not recruiting

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaidô, 060-8648

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Active, not recruiting

  • Osaka University Hospital

    Suita-Shi, Ôsaka, 565-0871

    Recruiting

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

    Active, not recruiting

  • Yamaguchi University Hospital

    Ube-Shi, Yamaguchi, 755-8505

    Active, not recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Completed

Other trials in Japan

Spain12 sites, 2 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron

    Barcelona, 8035

    Completed

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Withdrawn

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Completed

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Completed

  • Hospital Universitario La Paz

    Madrid, 28048

    Active, not recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Recruiting

  • Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago

    Santiago de Compostela, A Coruna, 15706

    Completed

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Active, not recruiting

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

    Withdrawn

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Active, not recruiting

Other trials in Spain

France11 sites, 3 recruiting

  • CHU Besancon

    Besançon, Cedex, 25030

    Withdrawn

  • CHU Brest Hôpital de la Cavale Blanche

    Brest, 29200

    Active, not recruiting

  • CHU Estaing

    Clermont-Ferrand, 63100

    Active, not recruiting

  • Hospital Beaujon University

    Clichy, 92110

    Active, not recruiting

  • Hopital Henri Mondor

    Créteil, 94010

    Active, not recruiting

  • CHU Montepellier - Hôpital Saint Eloi

    Montpellier, 34000

    Completed

  • CHU de Bordeaux - Hôpital Haut Leveque

    Pessac, Cedex, 33604

    Recruiting

  • CHU Poitiers

    Poitiers, 86000

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

    Completed

  • CHU de Toulouse- (Toulouse University Hospital Center)

    Toulouse, Cedex 9, 31059

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Completed

Other trials in France

Italy11 sites, 4 recruiting

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

    Candiolo, Torino, 10060

    Completed

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

    Recruiting

  • Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula

    Monserrato, Cagliari, 9042

    Active, not recruiting

  • AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli

    Naples, 80131

    Completed

  • Veneto Institute of Oncology IOV - I.R.C.C.S.

    Padova, 35128

    Completed

  • Azienda Ospedaliero - Universitaria Pisana

    Pisa, 56126

    Completed

  • Fondazione Policlinico Universitario Gemelli-IRCCS

    Roma, 00168

    Active, not recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia

    Udine, 33100

    Completed

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

    Recruiting

Other trials in Italy

South Korea11 sites, 2 recruiting

  • CHA Bundang Medical Center, CHA University

    Bundang-Gu, Seongnam-Si, Gyeonggi-do, 13496

    Active, not recruiting

  • Pusan National University Hospital

    Busan, 49241

    Completed

  • National Cancer Center

    Ilsandong-gu, Goyang-si, Gyeonggi-do, 10408

    Active, not recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Active, not recruiting

  • Korea University Anam Hospital

    Seoul, 2841

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

    Active, not recruiting

  • Hanyang University Seoul Hospital

    Seoul, 4763

    Withdrawn

  • Asan Medical Center

    Seoul, 5505

    Recruiting

  • Samsung Medical Center

    Seoul, 6351

    Recruiting

  • Korea University Guro Hospital

    Seoul, 8308

    Completed

Other trials in South Korea

China10 sites, 7 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410016

    Completed

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Completed

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150086

    Recruiting

  • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)

    Hefei, Anhui, 230036

    Recruiting

  • Shandong Provincial Third Hospital

    Jinan, Shandong, 250000

    Completed

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

    Recruiting

Other trials in China

Germany10 sites, 6 recruiting

  • Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie

    Berlin, 13353

    Active, not recruiting

  • Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus

    Dresden, Saxony, 01307

    Recruiting

  • Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK)

    Frankfurt am Main, Hesse, 60488

    Recruiting

  • Universitätsklinikum Freiburg - Klinik für Innere Medizin II,

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Completed

  • Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie

    Hamburg, 22763

    Recruiting

  • Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie

    Hanover, Nieder-Sachsen, 30625

    Recruiting

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Completed

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI)

    Lübeck, Schleswig-Holstein, 23562

    Recruiting

  • LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie

    München, Bavaria, 81377

    Completed

  • Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I

    Tübingen, Baden-Wuttemberg, 72076

    Recruiting

Other trials in Germany

Argentina8 sites, 4 recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autónoma de Buenos Aires (caba), Buenos Altes, C1199ABB

    Active, not recruiting

  • Centro Médico Privado CEMAIC

    Córdoba, X5008HHW

    Completed

  • Hospital Provincial Del Centenario

    Rosario, Santa Fe Province, 2000

    Completed

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe Province, S2013DTC

    Recruiting

  • CAIPO Centro para la Atención Integral del Paciente Oncológico

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

  • Centro Médico en Oncología Clínica EXELSUS S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

  • Fundación ARS Médica

    San Salvador de Jujuy, Jujuy Province, 4600

    Completed

  • Centro de Investigaciónes Clínicas - Clínica Viedma

    Viedma, Río Negro Province, R8500ACE

    Recruiting

Other trials in Argentina

Brazil8 sites, 1 recruiting

  • Fundação Pio XII Hospital de Amor de Barretos

    Barretos, São Paulo, 14.784-400

    Completed

  • Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

    Active, not recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59062-000

    Active, not recruiting

  • Hospital de Clinicas de Porto Alegre - HCPA

    Porto Alegre, Rio Grande do Sul, 90035-903

    Completed

  • Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC

    Porto Alegre, 91350-200

    Recruiting

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA

    Porto Alegrev, Rio Grande do Sul, 90020-170

    Active, not recruiting

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, 20230-130

    Active, not recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME)

    São José do Rio Preto, São Paulo, 15090-000

    Completed

Other trials in Brazil

Chile8 sites, 5 recruiting

  • Clinica Puerto Montt

    Port Montt, Los Lagos Region, 5507642

    Completed

  • Servicios Médicos URUMED SpA

    Rancagua, Libertador Gen Bernardo O Higgins, 2820000

    Completed

  • Centro de Investigacion y Especialidades Medicas (CDIEM)

    Santiago, Santiago Metropolitan, 7500859

    Recruiting

  • Fundación Arturo López Pérez (FALP)

    Santiago, Santiago Metropolitan, 7500921

    Completed

  • Oncovida

    Santiago, Santiago Metropolitan, 7500994

    Recruiting

  • Biocinetic Ltda

    Santiago, Santiago Metropolitan, 8320000

    Recruiting

  • Hospital Clinico Universidad de Chile

    Santiago, Santiago Metropolitan, 8380494

    Recruiting

  • James Lind Centro de Investigacion del Cancer

    Temuco, Araucania, 4800827

    Recruiting

Other trials in Chile

India8 sites, 2 recruiting

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

    Active, not recruiting

  • AIG Hospitals (A Unit of Asian Institute of Gastroenterology)

    Hyderabad, Telangana, 500032

    Completed

  • Pi Health Cancer Hospital

    Hyderabad, Telangana, 500032

    Completed

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 4000012

    Recruiting

  • Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute

    Nashik, Maharashtra, 422005

    Completed

  • Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation)

    New Delhi, 110017

    Completed

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, 110085

    Completed

  • Mahamana Pandit Madan Mohan Malviya Cancer Centre

    Varanasi, Uttar Pradesh, 221005

    Recruiting

Other trials in India

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 3109601

    Active, not recruiting

  • The Hadassah University Medical Center, Ein Kerem Hospital

    Jerusalem, 91120

    Active, not recruiting

  • Rabin Medical Center, Bellinson Hospital

    Petah Tikva, 49100

    Completed

  • The Chaim Sheba Medical Center, Tel Hashomer

    Ramat Gan, HaMerkaz, 5265601

    Active, not recruiting

  • Tel Aviv Sourasky Medical Center (Ichilov)

    Tel Aviv, 6423906

    Completed

Other trials in Israel

Portugal5 sites, 1 recruiting

  • Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267

    Active, not recruiting

  • Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3004-561

    Recruiting

  • Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos

    Lisbon, 1150-314

    Active, not recruiting

  • Champalimaud Clinical Center

    Lisbon, 1400-038

    Active, not recruiting

  • Instituto Português de Oncologia Do Porto Francisco Gentil, EPE

    Porto, 4200-072

    Active, not recruiting

Other trials in Portugal

Taiwan5 sites, 2 recruiting

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation

    Kaohsiung City, 833

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Completed

  • National Taiwan University Cancer Center

    Taipei, 106

    Active, not recruiting

  • Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

United Kingdom5 sites, 3 recruiting

  • Western General Hospital, Edinburgh Cancer Centre

    Edinburgh, Scotland, EH4 2XU

    Active, not recruiting

  • Mount Vernon Cancer Centre

    London, England, HA 6 2RN

    Recruiting

  • NHS Foundation Trust Royal Marsden Hospital

    London, England, SW3 6JJ

    Active, not recruiting

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

    Recruiting

  • Royal Marsden Hospital NHS Foundation Trust

    Surrey, England, SM2 5PT

    Recruiting

Other trials in United Kingdom

Romania4 sites, 1 recruiting

  • Institutul Clinic Fundeni

    Bucharest, 22328

    Withdrawn

  • Centrul De Oncologie "SF. Nectarie" S.R.L.

    Craiova, Dolj, 200542

    Withdrawn

  • Centrul de Oncologie Euroclinic SRL

    Iași, 700106

    Withdrawn

  • Spital Clinic Judetean de Urgenta Bihor

    Oradea, Bihor County, 410169

    Recruiting

Other trials in Romania

Turkey (Türkiye)4 sites, 3 recruiting

  • Hacettepe University Cancer Institute

    Ankara, Sihhiye, 06230

    Completed

  • Akdeniz University Medical Faculty Hospital

    Antalya, 07070

    Recruiting

  • Trakya University Faculty of Medicine

    Edirne, 22030

    Recruiting

  • Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research Center

    Istanbul, Fatih, 34096

    Recruiting

Other trials in Turkey (Türkiye)

Belgium3 sites, 2 recruiting

  • Imelda VZW

    Bonheiden, Antwerpen, 2820

    Recruiting

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

    Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

    Active, not recruiting

Other trials in Belgium

Canada3 sites, 1 recruiting

  • London Health Sciences Centre

    London, Ontario, NGA 5W9

    Active, not recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1

    Completed

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Czechia3 sites

  • Fakultní nemocnice Brno, Interní hematologická a onkologická klinika

    Brno, 625 00

    Withdrawn

  • Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie

    Hradec Králové, 50005

    Withdrawn

  • Fakultni nemocnice v Motole, Onkologicka klinika

    Prague, 150 00

    Withdrawn

Other trials in Czechia

Finland3 sites, 3 recruiting

  • Docrates Cancer Center

    Helsinki, 180

    Recruiting

  • Comprehensive Cancer Center, Helsinki University Hospital

    Helsinki, 290

    Recruiting

  • Kuopio University Hospital

    Kuopio, 70029

    Recruiting

Other trials in Finland

Serbia3 sites

  • University Clinical Center of Serbia, Clinic for Gastroenterohepatology

    Belgrade, 11000

    Withdrawn

  • Military Medical Academy, Clinic for Gastroenterology and Hepatology

    Belgrade, 11040

    Withdrawn

  • Oncology Institute of Vojvodina, Internal Oncology Clinic

    Kamenitz, 21204

    Withdrawn

Other trials in Serbia

Sweden3 sites, 2 recruiting

  • Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

    Recruiting

  • Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge

    Huddinge, 14186

    Recruiting

  • Onkologiska mottagningen, Skånes Universitetssjukhus Malmö

    Malmö, 205 02

    Withdrawn

Other trials in Sweden

Puerto Rico1 site, 1 recruiting

  • Hospital Oncologico, Puerto Rico Medical Center

    Rio Piedras, 935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.

Being tested
Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab, Durvalumab
Keywords
JZP598, ZW25, HER-2 positive BIliary Tract cancer, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma (ICC), Extrahepatic Cholangiocarcinoma (ECC), Zanidatamab, HER-2 overexpression, HER-2 amplification
Medical subject headings
Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma

What participants receive

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

  • ZanidatamabDrug

    Also called ZW25, JZP598, ZIIHERA®

    Administered intravenously (IV)

  • CisplatinDrug

    Administered intravenously (IV)

  • GemcitabineDrug

    Administered intravenously (IV)

  • PembrolizumabDrug

    Administered intravenously (IV)

  • DurvalumabDrug

    Administered intravenously (IV)

Study groups in NCT06282575
Study groupRoleWhat they receive
Zanidatamab with Standard-of-care Therapy ArmExperimentalZanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
Receives: Drug: Zanidatamab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Durvalumab
Standard-of-care Therapy ArmActive comparatorStandard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Durvalumab

What is being measured

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

  1. Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors

    PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.

    Measured: Up to 52 months

Secondary outcomes (12)

  1. Overall survival (OS) in participants with IHC 3+ tumors

    OS is defined as the time from randomization to death, due to any cause.

    Measured: Up to 68 months

  2. Progression Free Survival for all participants

    PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.

    Measured: Up to 68 months

  3. OS for all participants

    OS is defined as the time from randomization to death, due to any cause.

    Measured: Up to 68 months

  4. Number of participants achieving Confirmed objective response rate (cORR)

    Confirmed objective response rate is defined as achieving a confirmed best overall response of Complete Response (CR) or Partial Response (PR)

    Measured: Up to 68 months

  5. Duration of response (DOR)

    Duration of response is defined as the time from the first objective response (CR or PR) to documented Progressive Disease (PD) or death, from any cause.

    Measured: Up to 68 months

  6. Number of Patients reporting Treatment-Emergent Adverse Events (TEAE)

    Measured: Up to 68 months

  7. Maximum serum concentration of Zanidatamab

    Measured: Up to 68 months

  8. Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab

    Measured: Up to 68 months

  9. Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30

    TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) final scores range from 0 to 100, where higher scores reflect better functioning

    Measured: Up to 68 months

  10. TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30

    TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-C30 final scores range from 0 to 100, where higher scores reflect better functioning.

    Measured: Up to 68 months

  11. TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis)

    TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21) (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.

    Measured: Up to 68 months

  12. TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis)

    TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.

    Measured: Up to 68 months

Timeline

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

  1. First posted28 Feb 2024
  2. Study start19 Jul 2024
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Apr 2030 (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
Masking
None (open label)
Enrolment
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282575
Sponsor's protocol ID
JZP598-302
Other IDs
2023-508219-21-00, 2023
Status last verified
Oct 2026
First submitted
21 Feb 2024
Last updated
28 Oct 2026
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zanidatamab, Cisplatin and Gemcitabine in people with Biliary Tract Cancer, run by Jazz Pharmaceuticals at 185 sites in 25 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 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 185 sites in United States, Japan, Spain, France, Italy and 20 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?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors (time frame: Up to 52 months). 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 NCT06282575.

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 28 Oct 2026.

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