Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
NCT ID: NCT06282575
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2024-07-19
2030-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Zanidatamab
Administered intravenously (IV)
Cisplatin
Administered intravenously (IV)
Gemcitabine
Administered intravenously (IV)
Pembrolizumab
Administered intravenously (IV)
Durvalumab
Administered intravenously (IV)
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.
Cisplatin
Administered intravenously (IV)
Gemcitabine
Administered intravenously (IV)
Pembrolizumab
Administered intravenously (IV)
Durvalumab
Administered intravenously (IV)
Interventions
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Zanidatamab
Administered intravenously (IV)
Cisplatin
Administered intravenously (IV)
Gemcitabine
Administered intravenously (IV)
Pembrolizumab
Administered intravenously (IV)
Durvalumab
Administered intravenously (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
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
Servicios Médicos URUMED SpA
Rancagua, Libertador Gen Bernardo O Higgins, Chile
Clinica Puerto Montt
Port Montt, Los Lagos Region, Chile
James Lind Centro de Investigacion del Cancer
Temuco, Región de la Araucanía, 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
Napoli, , Italy
Veneto Institute of Oncology IOV - I.R.C.C.S.
Padua, , 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
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
Malmo, , 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 District, , 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
Countries
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Central Contacts
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Other Identifiers
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2023-508219-21-00
Identifier Type: OTHER
Identifier Source: secondary_id
JZP598-302
Identifier Type: -
Identifier Source: org_study_id