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

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Zanidatamab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Durvalumab

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trial Disclosure & Transparency; Phone Number: 215-832-3750; Email: ClinicalTrialDisclosure@JazzPharma.com

Study Locations

• Argentina
  • Córdoba, Argentina, X5008HHW
    • Recruiting
    • Centro médico privado Cemaic
  • Buenos Altes
    • Ciudad Autónoma de Buenos Aires (caba), Buenos Altes, Argentina, C1199ABB
      • Recruiting
      • Hospital Italiano de Buenos Aires
  • Jujuy Province
    • San Salvador de Jujuy, Jujuy Province, Argentina, 4600
      • Recruiting
      • Fundación Ars Médica
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500ACE
      • Recruiting
      • Centro de Investigaciónes Clínicas - Clínica Viedma
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Recruiting
      • Hospital Provincial del Centenario
    • Rosario, Santa Fe Province, Argentina, S2013DTC
      • Recruiting
      • Instituto Médico de la Fundación Estudios Clínicos
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Recruiting
      • CAIPO Centro para la Atencion Integral del Paciente Oncologico
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Recruiting
      • Centro Médico en Oncología Clínica EXELSUS S.R.L
• Belgium
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Recruiting
      • Imelda VZW
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • UZ Antwerpen
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
• Brazil
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC
  • Rio de Janeiro, Brazil, 20230-130
    • Recruiting
    • Instituto Nacional de Cancer - INCa
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Recruiting
      • Liga Norte Riograndense Contra o Câncer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre - HCPA
    • Porto Alegrev, Rio Grande do Sul, Brazil, 90020-170
      • Recruiting
      • Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA
  • São Paulo
    • Barretos, São Paulo, Brazil, 14.784-400
      • Recruiting
      • Fundacao Pio Xii Hospital de Amor de Barretos
    • Jaú, São Paulo, Brazil, 17210-080
      • Recruiting
      • Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Recruiting
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME)
• Canada
  • Ontario
    • London, Ontario, Canada, NGA 5W9
      • Recruiting
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre - University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre hospitalier de l'Université de Montréal (CHUM)
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • Recruiting
      • James Lind Centro de Investigacion del Cancer
  • Libertador Gen Bernardo O Higgins
    • Rancagua, Libertador Gen Bernardo O Higgins, Chile, 2820000
      • Recruiting
      • Servicios Médicos URUMED SpA
  • Los Lagos Region
    • Port Montt, Los Lagos Region, Chile, 5507642
      • Recruiting
      • Clinica Puerto Montt
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Recruiting
      • Fundación Arturo López Pérez (FALP)
    • Santiago, Santiago Metropolitan, Chile, 7500859
      • Recruiting
      • Centro de Investigacion y Especialidades Medicas (CDIEM)
    • Santiago, Santiago Metropolitan, Chile, 7500994
      • Recruiting
      • Oncovida
    • Santiago, Santiago Metropolitan, Chile, 8320000
      • Recruiting
      • BIOCINETIC Ltda
    • Santiago, Santiago Metropolitan, Chile, 8380494
      • Recruiting
      • Hospital Clínico Universidad de Chile
• China
  • Shanghai, China, 200032
    • Recruiting
    • ZhongShan Hospital FuDan University
  • Anhui
    • Hefei, Anhui, China, 230036
      • Active, not recruiting
      • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Active, not recruiting
      • Beijing Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Active, not recruiting
      • The First Hospital of Lanzhou University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410016
      • Recruiting
      • Hunan Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Shandong Provincial Third Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer hospital
    • Chengdu, Sichuan, China, 610041
      • Active, not recruiting
      • West China Hospital Sichuan University
• Czechia
  • Brno, Czechia, 625 00
    • Withdrawn
    • Fakultní nemocnice Brno, Interní hematologická a onkologická klinika
  • Hradec Králové, Czechia, 50005
    • Withdrawn
    • Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie
  • Prague, Czechia, 150 00
    • Withdrawn
    • Fakultni nemocnice v Motole, Onkologicka klinika
• Finland
  • Helsinki, Finland, 180
    • Recruiting
    • Docrates Cancer Center
  • Helsinki, Finland, 290
    • Recruiting
    • Comprehensive Cancer Center, Helsinki University Hospital
  • Kuopio, Finland, 70029
    • Recruiting
    • Kuopio University Hospital
• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest Hôpital de la Cavale Blanche
  • Clermont-Ferrand, France, 63100
    • Recruiting
    • Chu Estaing
  • Clichy, France, 92110
    • Recruiting
    • Hospital Beaujon University
  • Créteil, France, 94010
    • Recruiting
    • Hôpital Henri Mondor
  • Montpellier, France, 34000
    • Recruiting
    • CHU Montepellier - Hôpital Saint Eloi
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancérologie de l'Ouest
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
  • Cedex
    • Besançon, Cedex, France, 25030
      • Recruiting
      • CHU Besançon
    • Pessac, Cedex, France, 33604
      • Recruiting
      • CHU de Bordeaux - Hôpital Haut Leveque
  • Cedex 9
    • Toulouse, Cedex 9, France, 31059
      • Recruiting
      • CHU de Toulouse- (Toulouse University Hospital Center)
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie
  • Hamburg, Germany, 22763
    • Recruiting
    • Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Recruiting
      • Universitätsklinikum Freiburg - Klinik für Innere Medizin II,
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Recruiting
      • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
  • Baden-Wuttemberg
    • Tübingen, Baden-Wuttemberg, Germany, 72076
      • Active, not recruiting
      • Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Recruiting
      • LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60488
      • Recruiting
      • Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK)
  • Nieder-Sachsen
    • Hanover, Nieder-Sachsen, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Recruiting
      • Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI)
• India
  • New Delhi, India, 110085
    • Recruiting
    • Rajiv Gandhi Cancer Institute And Research Centre
  • New Delhi, India, 110017
    • Recruiting
    • Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation)
  • Karnataka
    • Belagavi, Karnataka, India, 590010
      • Recruiting
      • KLES Dr Prabhakar Kore Hospital and Medical Research Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 4000012
      • Active, not recruiting
      • Tata Memorial hospital
    • Nashik, Maharashtra, India, 422005
      • Recruiting
      • Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • Recruiting
      • AIG Hospitals (A Unit of Asian Institute of Gastroenterology)
    • Hyderabad, Telangana, India, 500032
      • Recruiting
      • Pi Health Cancer Hospital
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221005
      • Recruiting
      • Mahamana Pandit Madan Mohan Malviya Cancer Centre
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Recruiting
    • The Hadassah University Medical Center, Ein Kerem Hospital
  • Petah Tikva, Israel, 49100
    • Recruiting
    • Rabin Medical Center, Bellinson Hospital
  • Ramat Gan, HaMerkaz, Israel, 5265601
    • Recruiting
    • The Chaim Sheba Medical Center, Tel Hashomer
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center (Ichilov)
• Italy
  • Genova, Italy, 16132
    • Recruiting
    • IRCCS Ospedale Policlinico San Martino
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori
  • Naples, Italy, 80131
    • Recruiting
    • AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli
  • Padova, Italy, 35128
    • Recruiting
    • Veneto Institute of Oncology IOV - I.R.C.C.S.
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero - Universitaria Pisana
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Gemelli-IRCCS
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
  • Udine, Italy, 33100
    • Recruiting
    • Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia
  • Verona, Italy, 37134
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
  • Cagliari
    • Monserrato, Cagliari, Italy, 9042
      • Recruiting
      • Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Recruiting
      • Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS)
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-1395
      • Recruiting
      • National Hospital Organization Kyushu Cancer Center
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 9208641
      • Recruiting
      • Kanazawa University Hospital
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-8520
      • Recruiting
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Cancer Center
  • Kyôto
    • Kyoto, Kyôto, Japan, 606-8507
      • Recruiting
      • Kyoto University Hospital
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Recruiting
      • Mie University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Recruiting
      • Niigata University Medical and Dental Hospital
  • Osaka
    • Osaka, Osaka, Japan, 541-8567
      • Recruiting
      • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Recruiting
      • The University of Tokyo Hospital
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
    • Koto-Ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Recruiting
      • Kyorin University Hospital
  • Yamaguchi
    • Ube-Shi, Yamaguchi, Japan, 755-8505
      • Recruiting
      • Yamaguchi University Hospital
  • Ôsaka
    • Suita-Shi, Ôsaka, Japan, 565-0871
      • Active, not recruiting
      • Osaka University Hospital
• Portugal
  • Almada, Portugal, 2805-267
    • Recruiting
    • Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta
  • Coimbra, Portugal, 3004-561
    • Recruiting
    • Unidade Local de Saúde de Coimbra, EPE - Hospitais da Universidade de Coimbra
  • Lisbon, Portugal, 1400-038
    • Recruiting
    • Champalimaud Clinical Center
  • Lisbon, Portugal, 1150-314
    • Recruiting
    • Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos
  • Porto, Portugal, 4200-072
    • Recruiting
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
• Puerto Rico
  • Rio Piedras, Puerto Rico, 935
    • Recruiting
    • Hospital Oncologico, Puerto Rico Medical Center
• Romania
  • Bucharest, Romania, 22328
    • Withdrawn
    • Institutul Clinic Fundeni
  • Iași, Romania, 700106
    • Active, not recruiting
    • Centrul de Oncologie Euroclinic srl
  • Bihor County
    • Oradea, Bihor County, Romania, 410169
      • Active, not recruiting
      • Spital Clinic Judetean de Urgenta Bihor
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Active, not recruiting
      • Centrul De Oncologie "SF. Nectarie" S.R.L.
• Serbia
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • University Clinical Center of Serbia, Clinic for Gastroenterohepatology
  • Belgrade, Serbia, 11040
    • Active, not recruiting
    • Military Medical Academy, Clinic for Gastroenterology and Hepatology
  • Kamenitz, Serbia, 21204
    • Withdrawn
    • Oncology Institute of Vojvodina, Internal Oncology Clinic
• South Korea
  • Busan, South Korea, 49241
    • Recruiting
    • Pusan National University Hospital
  • Seoul, South Korea, 6351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 5505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 3722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 8308
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, South Korea, 3080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 2841
    • Recruiting
    • Korea University Anam Hospital
  • Seoul, South Korea, 4763
    • Withdrawn
    • Hanyang University Seoul Hospital
  • Gyeonggi-do
    • Bundang-Gu, Seongnam-Si, Gyeonggi-do, South Korea, 13496
      • Recruiting
      • Cha Bundang Medical Center, Cha University
    • Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 8035
    • Recruiting
    • Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28048
    • Recruiting
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Málaga
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Universidad de Navarra
  • Seville, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Active, not recruiting
    • Hospital Universitario y Politécnico La Fe
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Recruiting
      • Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago
• Sweden
  • Gothenburg, Sweden, 413 45
    • Active, not recruiting
    • Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset
  • Huddinge, Sweden, 14186
    • Recruiting
    • Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge
  • Malmö, Sweden, 205 02
    • Withdrawn
    • Onkologiska mottagningen, Skånes Universitetssjukhus Malmö
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 07070
    • Recruiting
    • Akdeniz University Medical Faculty Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Recruiting
    • Trakya University Faculty of Medicine
  • Fatih
    • Istanbul, Fatih, Turkey (Türkiye), 34096
      • Recruiting
      • Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research Center
  • Sihhiye
    • Ankara, Sihhiye, Turkey (Türkiye), 06230
      • Recruiting
      • Hacettepe University Cancer Institute
• United Kingdom
  • England
    • London, England, United Kingdom, HA 6 2RN
      • Recruiting
      • Mount Vernon Cancer Centre
    • London, England, United Kingdom, SW3 6JJ
      • Recruiting
      • NHS Foundation Trust Royal Marsden Hospital
    • Manchester, England, United Kingdom, M20 4BX
      • Recruiting
      • The Christie NHS Foundation Trust
    • Surrey, England, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden Hospital NHS Foundation Trust
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH4 2XU
      • Recruiting
      • Western General Hospital, Edinburgh Cancer Centre
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope(City of Hope National Medical Center, City of Hope Medical Center)
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Withdrawn
      • Rocky Mountain Cancer Centers, LLP
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Hematology and Oncology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Winship Cancer Institute
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Withdrawn
      • The University of Kansas Cancer Center - Westwood
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Recruiting
      • Norton Cancer Institute - Audubon
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Active, not recruiting
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Hospital
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • Active, not recruiting
      • Minnesota Oncology Hematology, P.A.
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Active, not recruiting
      • Atlantic Health System/Morristown Medical Center
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Memorial Sloan Kettering Cancer Centers
    • New York, New York, United States, 10016
      • Recruiting
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health and Science University
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Saint Francis Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • Scri Oncology Partners
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Active, not recruiting
      • Texas Oncology - DFW
    • Houston, Texas, United States, 77030
      • Recruiting
      • The Univerrsity of Texas MD Anderson Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Recruiting
      • Virginia Commonwealth University, VCU Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
2. Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
3. 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.
4. 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.
5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
6. Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Adequate organ function
9. Females of childbearing potential must have a negative pregnancy test result.
10. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Exclusion Criteria

1. Prior treatment with a HER2-targeted agent
2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
3. 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.
4. Use of systemic corticosteroids.
5. Brain metastases
6. Severe chronic or active infections
7. History of allogeneic organ transplantation.
8. Active or prior autoimmune inflammatory conditions
9. History of interstitial lung disease or non-infectious pneumonitis.
10. Participation in another clinical trial with an investigational medicinal product within the last 3 months.
11. Females who are breastfeeding
12. Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
13. Use of phenytoin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zanidatamab with Standard-of-care Therapy Arm; Zanidatamab 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.	Drug: Zanidatamab; Administered intravenously (IV); Other Names: ZW25; JZP598; ZIIHERA®; Drug: Cisplatin; Administered intravenously (IV); Drug: Gemcitabine; Administered intravenously (IV); Drug: Pembrolizumab; Administered intravenously (IV); Drug: Durvalumab; Administered intravenously (IV)
Active Comparator: Standard-of-care Therapy Arm; 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.	Drug: Cisplatin; Administered intravenously (IV); Drug: Gemcitabine; Administered intravenously (IV); Drug: Pembrolizumab; Administered intravenously (IV); Drug: Durvalumab; Administered intravenously (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 52 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) in participants with IHC 3+ tumors	OS is defined as the time from randomization to death, due to any cause.	Up to 68 months
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.	Up to 68 months
OS for all participants	OS is defined as the time from randomization to death, due to any cause.	Up to 68 months
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)	Up to 68 months
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.	Up to 68 months
Number of Patients reporting Treatment-Emergent Adverse Events (TEAE)		Up to 68 months
Maximum serum concentration of Zanidatamab		Up to 68 months
Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab		Up to 68 months
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	Up to 68 months
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.	Up to 68 months
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.	Up to 68 months
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.	Up to 68 months

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Gallbladder Cancer; ZW25; JZP598; HER-2 positive BIliary Tract cancer; Intrahepatic Cholangiocarcinoma (ICC); Extrahepatic Cholangiocarcinoma (ECC); Zanidatamab; HER-2 overexpression; HER-2 amplification
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Gallbladder Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Cisplatin; pembrolizumab; durvalumab; zanidatamab
• Other Study ID Numbers: JZP598-302; 2023-508219-21-00 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No