RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Jazz Pharmaceuticals • ClinicalTrials.gov ID: NCT06282575

Registry updated: 2026-09-14

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Description

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.

Interventions

Zanidatamab (Drug)
Administered intravenously (IV)
Cisplatin (Drug)
Administered intravenously (IV)
Gemcitabine (Drug)
Administered intravenously (IV)
Pembrolizumab (Drug)
Administered intravenously (IV)
Durvalumab (Drug)
Administered intravenously (IV)

Eligibility criteria

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

Conditions

Biliary Tract Cancer

Locations

City of Hope(City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
AdventHealth Hematology and Oncology — Orlando, Florida, United States
Winship Cancer Institute — Atlanta, Georgia, United States
The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
Norton Cancer Institute - Audubon — Louisville, Kentucky, United States
Ochsner Clinic Foundation — New Orleans, Louisiana, United States
Tufts Medical Center — Boston, Massachusetts, United States
University of Michigan Hospital — Ann Arbor, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A. — Maple Grove, Minnesota, United States
Atlantic Health System/Morristown Medical Center — Morristown, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center — New York, New York, United States
Memorial Sloan Kettering Cancer Centers — New York, New York, United States
Oregon Health and Science University — Portland, Oregon, United States
Saint Francis Cancer Center — Greenville, South Carolina, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
Texas Oncology - DFW — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
The Univerrsity of Texas MD Anderson Cancer Center — Houston, Texas, United States
Virginia Commonwealth University, VCU Health — Richmond, Virginia, United States
Hospital Italiano de Buenos Aires — Ciudad Autónoma de Buenos Aires (caba), Buenos Altes, Argentina
Fundación ARS Médica — San Salvador de Jujuy, Jujuy Province, Argentina
Centro de Investigaciónes Clínicas - Clínica Viedma — Viedma, Río Negro Province, Argentina
Hospital Provincial Del Centenario — Rosario, Santa Fe Province, Argentina
Instituto Médico de la Fundación Estudios Clínicos — Rosario, Santa Fe Province, Argentina
CAIPO Centro para la Atención Integral del Paciente Oncológico — San Miguel de Tucumán, Tucumán Province, Argentina
Centro Médico en Oncología Clínica EXELSUS S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina
Centro Médico Privado CEMAIC — Córdoba, Argentina
Imelda VZW — Bonheiden, Antwerpen, Belgium
UZ Antwerpen — Edegem, Antwerpen, Belgium
UZ Leuven — Leuven, Vlaams-Brabant, Belgium
Liga Norte Riograndense Contra O Cancer — Natal, Rio Grande do Norte, Brazil
Hospital de Clinicas de Porto Alegre - HCPA — Porto Alegre, Rio Grande do Sul, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA — Porto Alegrev, Rio Grande do Sul, Brazil
Fundação Pio XII Hospital de Amor de Barretos — Barretos, São Paulo, Brazil
Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho — Jaú, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME) — São José do Rio Preto, São Paulo, Brazil
Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC — Porto Alegre, Brazil
Instituto Nacional de Cancer - INCA — Rio de Janeiro, Brazil
London Health Sciences Centre — London, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada
James Lind Centro de Investigacion del Cancer — Temuco, Araucania, Chile
Servicios Médicos URUMED SpA — Rancagua, Libertador Gen Bernardo O Higgins, Chile
Clinica Puerto Montt — Port Montt, Los Lagos Region, Chile
Centro de Investigacion y Especialidades Medicas (CDIEM) — Santiago, Santiago Metropolitan, Chile
Fundación Arturo López Pérez (FALP) — Santiago, Santiago Metropolitan, Chile
Oncovida — Santiago, Santiago Metropolitan, Chile
Biocinetic Ltda — Santiago, Santiago Metropolitan, Chile
Hospital Clinico Universidad de Chile — Santiago, Santiago Metropolitan, Chile
The First Affiliated Hospital of USTC(Anhui Provincial Hospital) — Hefei, Anhui, China
Beijing Cancer Hospital — Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University — Lanzhou, Gansu, China
Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
Hunan Provincial People's Hospital — Changsha, Hunan, China
Jilin Cancer Hospital — Changchun, Jilin, China
Shandong Provincial Third Hospital — Jinan, Shandong, China
Sichuan Cancer Hospital — Chengdu, Sichuan, China
West China Hospital Sichuan University — Chengdu, Sichuan, China
Zhongshan Hospital Fudan University — Shanghai, China
Fakultní nemocnice Brno, Interní hematologická a onkologická klinika — Brno, Czechia
Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie — Hradec Králové, Czechia
Fakultni nemocnice v Motole, Onkologicka klinika — Prague, Czechia
Docrates Cancer Center — Helsinki, Finland
Comprehensive Cancer Center, Helsinki University Hospital — Helsinki, Finland
Kuopio University Hospital — Kuopio, Finland
CHU de Toulouse- (Toulouse University Hospital Center) — Toulouse, Cedex 9, France
CHU Besancon — Besançon, Cedex, France
CHU de Bordeaux - Hôpital Haut Leveque — Pessac, Cedex, France
CHU Brest Hôpital de la Cavale Blanche — Brest, France
CHU Estaing — Clermont-Ferrand, France
Hospital Beaujon University — Clichy, France
Hopital Henri Mondor — Créteil, France
CHU Montepellier - Hôpital Saint Eloi — Montpellier, France
CHU Poitiers — Poitiers, France
Institut de Cancérologie de l'Ouest — Saint-Herblain, France
Gustave Roussy — Villejuif, France
Universitätsklinikum Freiburg - Klinik für Innere Medizin II, — Freiburg im Breisgau, Baden-Wurttemberg, Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I — Tübingen, Baden-Wuttemberg, Germany
LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie — München, Bavaria, Germany
Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK) — Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie — Hanover, Nieder-Sachsen, Germany
Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus — Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI) — Lübeck, Schleswig-Holstein, Germany
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie — Berlin, Germany
Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie — Hamburg, Germany
KLES Dr Prabhakar Kore Hospital and Medical Research Centre — Belagavi, Karnataka, India
Tata Memorial Hospital — Mumbai, Maharashtra, India
Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute — Nashik, Maharashtra, India
AIG Hospitals (A Unit of Asian Institute of Gastroenterology) — Hyderabad, Telangana, India
Pi Health Cancer Hospital — Hyderabad, Telangana, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre — Varanasi, Uttar Pradesh, India
Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation) — New Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre — New Delhi, India
Rambam Health Care Campus — Haifa, Israel
The Hadassah University Medical Center, Ein Kerem Hospital — Jerusalem, Israel
Rabin Medical Center, Bellinson Hospital — Petah Tikva, Israel
The Chaim Sheba Medical Center, Tel Hashomer — Ramat Gan, HaMerkaz, Israel
Tel Aviv Sourasky Medical Center (Ichilov) — Tel Aviv, Israel
Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula — Monserrato, Cagliari, Italy
Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS) — Candiolo, Torino, Italy
IRCCS Ospedale Policlinico San Martino — Genova, Italy
Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori — Milan, Italy
AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli — Naples, Italy
Veneto Institute of Oncology IOV - I.R.C.C.S. — Padova, Italy
Azienda Ospedaliero - Universitaria Pisana — Pisa, Italy
Fondazione Policlinico Universitario Gemelli-IRCCS — Roma, Italy
Istituto Clinico Humanitas — Rozzano, Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia — Udine, Italy
Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy
Aichi Cancer Center — Nagoya, Aichi-ken, Japan
Chiba Cancer Center — Chiba, Chiba, Japan
National Cancer Center Hospital East — Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center — Matsuyama, Ehime, Japan
National Hospital Organization Kyushu Cancer Center — Fukuoka, Fukuoka, Japan
Hokkaido University Hospital — Sapporo, Hokkaidô, Japan
Kanazawa University Hospital — Kanazawa, Ishikawa-ken, Japan
Kagoshima University Hospital — Kagoshima, Kagoshima-ken, Japan
Kanagawa Cancer Center — Yokohama, Kanagawa, Japan
Kyoto University Hospital — Kyoto, Kyôto, Japan
Mie University Hospital — Tsu, Mie-ken, Japan
Tohoku University Hospital — Sendai, Miyagi, Japan
Niigata University Medical and Dental Hospital — Niigata, Niigata, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute — Osaka, Osaka, Japan
The University of Tokyo Hospital — Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Koto-Ku, Tokyo, Japan
Kyorin University Hospital — Mitaka-shi, Tokyo, Japan
Yamaguchi University Hospital — Ube-Shi, Yamaguchi, Japan
Osaka University Hospital — Suita-Shi, Ôsaka, Japan
Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta — Almada, Portugal
Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra — Coimbra, Portugal
Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos — Lisbon, Portugal
Champalimaud Clinical Center — Lisbon, Portugal
Instituto Português de Oncologia Do Porto Francisco Gentil, EPE — Porto, Portugal
Hospital Oncologico, Puerto Rico Medical Center — Rio Piedras, Puerto Rico
Spital Clinic Judetean de Urgenta Bihor — Oradea, Bihor County, Romania
Centrul De Oncologie "SF. Nectarie" S.R.L. — Craiova, Dolj, Romania
Institutul Clinic Fundeni — Bucharest, Romania
Centrul de Oncologie Euroclinic SRL — Iași, Romania
University Clinical Center of Serbia, Clinic for Gastroenterohepatology — Belgrade, Serbia
Military Medical Academy, Clinic for Gastroenterology and Hepatology — Belgrade, Serbia
Oncology Institute of Vojvodina, Internal Oncology Clinic — Kamenitz, Serbia
CHA Bundang Medical Center, CHA University — Bundang-Gu, Seongnam-Si, Gyeonggi-do, South Korea
National Cancer Center — Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital — Busan, South Korea
Korea University Anam Hospital — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Severance Hospital, Yonsei University Health System — Seoul, South Korea
Hanyang University Seoul Hospital — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Korea University Guro Hospital — Seoul, South Korea
Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago — Santiago de Compostela, A Coruna, Spain
Hospital Clinic de Barcelona — Barcelona, Spain
Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron — Barcelona, Spain
Hospital Universitario Reina Sofia — Córdoba, Spain
Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitario La Paz — Madrid, Spain
Hospital Regional Universitario de Malaga — Málaga, Spain
Clinica Universidad de Navarra — Pamplona, Spain
Hospital Universitario Virgen Macarena — Seville, Spain
Hospital Universitario y Politecnico La Fe — Valencia, Spain
Hospital Universitario Miguel Servet — Zaragoza, Spain
Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden
Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge — Huddinge, Sweden
Onkologiska mottagningen, Skånes Universitetssjukhus Malmö — Malmö, Sweden
Kaohsiung Medical University - Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation — Kaohsiung City, Taiwan
National Cheng Kung University Hospital — Tainan, Taiwan
National Taiwan University Cancer Center — Taipei, Taiwan
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation — Taoyuan, Taiwan
Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research Center — Istanbul, Fatih, Turkey (Türkiye)
Hacettepe University Cancer Institute — Ankara, Sihhiye, Turkey (Türkiye)
Akdeniz University Medical Faculty Hospital — Antalya, Turkey (Türkiye)
Trakya University Faculty of Medicine — Edirne, Turkey (Türkiye)
Mount Vernon Cancer Centre — London, England, United Kingdom
NHS Foundation Trust Royal Marsden Hospital — London, England, United Kingdom
The Christie NHS Foundation Trust — Manchester, England, United Kingdom
Royal Marsden Hospital NHS Foundation Trust — Surrey, England, United Kingdom
Western General Hospital, Edinburgh Cancer Centre — Edinburgh, Scotland, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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