Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer | NCT06282575 | Trialant

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer | NCT06282575 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria

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).

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.

Exclusion Criteria

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

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

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

Duarte, California 91010, United States

Rocky Mountain Cancer Centers, LLPWithdrawn

Lone Tree, Colorado 80124, United States

AdventHealth Hematology and OncologyRecruiting

Orlando, Florida 32804, United States

Winship Cancer InstituteRecruiting

Atlanta, Georgia 30322, United States

The University of Kansas Cancer Center - WestwoodWithdrawn

Westwood, Kansas 66205, United States

Norton Cancer Institute - AudubonRecruiting

Louisville, Kentucky 40217, United States

Ochsner Clinic FoundationRecruiting

New Orleans, Louisiana 70121, United States

Tufts Medical CenterActive, not recruiting

Boston, Massachusetts 02111, United States

University of Michigan HospitalRecruiting

Ann Arbor, Michigan 48109, United States

Henry Ford Health SystemRecruiting

Detroit, Michigan 48202, United States

Minnesota Oncology Hematology, P.A.Active, not recruiting

Maple Grove, Minnesota 55369, United States

Atlantic Health System/Morristown Medical CenterActive, not recruiting

Morristown, New Jersey 07960, United States

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

New York, New York 10016, United States

Memorial Sloan Kettering Cancer CentersRecruiting

New York, New York 10022, United States

Oregon Health and Science UniversityActive, not recruiting

Portland, Oregon 97239, United States

Saint Francis Cancer CenterRecruiting

Greenville, South Carolina 29607, United States

SCRI Oncology PartnersActive, not recruiting

Nashville, Tennessee 37203, United States

Texas Oncology - DFWActive, not recruiting

Dallas, Texas 75246, United States

University of Texas Southwestern Medical CenterRecruiting

Dallas, Texas 75390, United States

The Univerrsity of Texas MD Anderson Cancer CenterRecruiting

Houston, Texas 77030, United States

Virginia Commonwealth University, VCU HealthRecruiting

Richmond, Virginia 23219, United States

Hospital Italiano de Buenos AiresRecruiting

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

Fundación ARS MédicaRecruiting

San Salvador de Jujuy, Jujuy Province 4600, Argentina

Centro de Investigaciónes Clínicas - Clínica ViedmaRecruiting

Viedma, Río Negro Province R8500ACE, Argentina

Hospital Provincial Del CentenarioRecruiting

Rosario, Santa Fe Province 2000, Argentina

Instituto Médico de la Fundación Estudios ClínicosRecruiting

Rosario, Santa Fe Province S2013DTC, Argentina

CAIPO Centro para la Atención Integral del Paciente OncológicoRecruiting

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Centro Médico en Oncología Clínica EXELSUS S.R.LRecruiting

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Centro Médico Privado CEMAICRecruiting

Córdoba, X5008HHW, Argentina

Imelda VZWRecruiting

Bonheiden, Antwerpen 2820, Belgium

UZ AntwerpenRecruiting

Edegem, Antwerpen 2650, Belgium

UZ LeuvenRecruiting

Leuven, Vlaams-Brabant 3000, Belgium

Liga Norte Riograndense Contra O CancerRecruiting

Natal, Rio Grande do Norte 59062-000, Brazil

Hospital de Clinicas de Porto Alegre - HCPARecruiting

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPARecruiting

Porto Alegrev, Rio Grande do Sul 90020-170, Brazil

Fundação Pio XII Hospital de Amor de BarretosRecruiting

Barretos, São Paulo 14.784-400, Brazil

Fundação Doutor Amaral Carvalho - Hospital Amaral CarvalhoRecruiting

Jaú, São Paulo 17210-080, Brazil

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

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

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

Porto Alegre, 91350-200, Brazil

Instituto Nacional de Cancer - INCARecruiting

Rio de Janeiro, 20230-130, Brazil

London Health Sciences CentreRecruiting

London, Ontario NGA 5W9, Canada

Princess Margaret Cancer Centre - University Health NetworkRecruiting

Toronto, Ontario M5G 2M9, Canada

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

Montreal, Quebec H2X 0C1, Canada

James Lind Centro de Investigacion del CancerRecruiting

Temuco, Araucania 4800827, Chile

Servicios Médicos URUMED SpARecruiting

Rancagua, Libertador Gen Bernardo O Higgins 2820000, Chile

Clinica Puerto MonttRecruiting

Port Montt, Los Lagos Region 5507642, Chile

Centro de Investigacion y Especialidades Medicas (CDIEM)Recruiting

Santiago, Santiago Metropolitan 7500859, Chile

Fundación Arturo López Pérez (FALP)Recruiting

Santiago, Santiago Metropolitan 7500921, Chile

OncovidaRecruiting

Santiago, Santiago Metropolitan 7500994, Chile

Biocinetic LtdaRecruiting

Santiago, Santiago Metropolitan 8320000, Chile

Hospital Clinico Universidad de ChileRecruiting

Santiago, Santiago Metropolitan 8380494, Chile

The First Affiliated Hospital of USTC(Anhui Provincial Hospital)Active, not recruiting

Hefei, Anhui 230036, China

Beijing Cancer HospitalActive, not recruiting

Beijing, Beijing Municipality 100142, China

The First Hospital of Lanzhou UniversityActive, not recruiting

Lanzhou, Gansu 730000, China

Harbin Medical University Cancer HospitalRecruiting

Harbin, Heilongjiang 150086, China

Hunan Provincial People's HospitalRecruiting

Changsha, Hunan 410016, China

Jilin Cancer HospitalRecruiting

Changchun, Jilin 130000, China

Shandong Provincial Third HospitalRecruiting

Jinan, Shandong 250000, China

Sichuan Cancer HospitalRecruiting

Chengdu, Sichuan 610041, China

West China Hospital Sichuan UniversityActive, not recruiting

Chengdu, Sichuan 610041, China

Zhongshan Hospital Fudan UniversityRecruiting

Shanghai, 200032, China

Fakultní nemocnice Brno, Interní hematologická a onkologická klinikaWithdrawn

Brno, 625 00, Czechia

Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapieWithdrawn

Hradec Králové, 50005, Czechia

Fakultni nemocnice v Motole, Onkologicka klinikaWithdrawn

Prague, 150 00, Czechia

Docrates Cancer CenterRecruiting

Helsinki, 180, Finland

Comprehensive Cancer Center, Helsinki University HospitalRecruiting

Helsinki, 290, Finland

Kuopio University HospitalRecruiting

Kuopio, 70029, Finland

CHU de Toulouse- (Toulouse University Hospital Center)Recruiting

Toulouse, Cedex 9 31059, France

CHU BesanconRecruiting

Besançon, Cedex 25030, France

CHU de Bordeaux - Hôpital Haut LevequeRecruiting

Pessac, Cedex 33604, France

CHU Brest Hôpital de la Cavale BlancheRecruiting

Brest, 29200, France

CHU EstaingRecruiting

Clermont-Ferrand, 63100, France

Hospital Beaujon UniversityRecruiting

Clichy, 92110, France

Hopital Henri MondorRecruiting

Créteil, 94010, France

CHU Montepellier - Hôpital Saint EloiRecruiting

Montpellier, 34000, France

CHU PoitiersRecruiting

Poitiers, 86000, France

Institut de Cancérologie de l'OuestRecruiting

Saint-Herblain, 44805, France

Gustave RoussyRecruiting

Villejuif, 94805, France

Universitätsklinikum Freiburg - Klinik für Innere Medizin II,Recruiting

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Nationales Centrum für Tumorerkrankungen (NCT) HeidelbergRecruiting

Heidelberg, Baden-Wurttemberg 69120, Germany

Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin IActive, not recruiting

Tübingen, Baden-Wuttemberg 72076, Germany

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

München, Bavaria 81377, Germany

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

Frankfurt am Main, Hesse 60488, Germany

Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und EndokrinologieRecruiting

Hanover, Nieder-Sachsen 30625, Germany

Technische Universität Dresden Medizinische Fakultät Carl Gustav CarusRecruiting

Dresden, Saxony 01307, Germany

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

Lübeck, Schleswig-Holstein 23562, Germany

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

Berlin, 13353, Germany

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

Hamburg, 22763, Germany

KLES Dr Prabhakar Kore Hospital and Medical Research CentreRecruiting

Belagavi, Karnataka 590010, India

Tata Memorial HospitalActive, not recruiting

Mumbai, Maharashtra 4000012, India

Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart InstituteRecruiting

Nashik, Maharashtra 422005, India

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

Hyderabad, Telangana 500032, India

Pi Health Cancer HospitalRecruiting

Hyderabad, Telangana 500032, India

Mahamana Pandit Madan Mohan Malviya Cancer CentreRecruiting

Varanasi, Uttar Pradesh 221005, India

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

New Delhi, 110017, India

Rajiv Gandhi Cancer Institute And Research CentreRecruiting

New Delhi, 110085, India

Rambam Health Care CampusRecruiting

Haifa, 3109601, Israel

The Hadassah University Medical Center, Ein Kerem HospitalRecruiting

Jerusalem, 91120, Israel

Rabin Medical Center, Bellinson HospitalRecruiting

Petah Tikva, 49100, Israel

The Chaim Sheba Medical Center, Tel HashomerRecruiting

Ramat Gan, HaMerkaz, 5265601, Israel

Tel Aviv Sourasky Medical Center (Ichilov)Recruiting

Tel Aviv, 6423906, Israel

Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio CasulaRecruiting

Monserrato, Cagliari 9042, Italy

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

Candiolo, Torino 10060, Italy

IRCCS Ospedale Policlinico San MartinoRecruiting

Genova, 16132, Italy

Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei TumoriRecruiting

Milan, 20133, Italy

AOU dell'Universit~ degli Studi della Campania Luigi VanvitelliRecruiting

Naples, 80131, Italy

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

Padova, 35128, Italy

Azienda Ospedaliero - Universitaria PisanaRecruiting

Pisa, 56126, Italy

Fondazione Policlinico Universitario Gemelli-IRCCSRecruiting

Roma, 00168, Italy

Istituto Clinico HumanitasRecruiting

Rozzano, 20089, Italy

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

Udine, 33100, Italy

Azienda Ospedaliera Universitaria Integrata VeronaRecruiting

Verona, 37134, Italy

Aichi Cancer CenterRecruiting

Nagoya, Aichi-ken 464-8681, Japan

Chiba Cancer CenterRecruiting

Chiba, Chiba 260-8717, Japan

National Cancer Center Hospital EastRecruiting

Kashiwa, Chiba 277-8577, Japan

National Hospital Organization Shikoku Cancer CenterRecruiting

Matsuyama, Ehime 791-0280, Japan

National Hospital Organization Kyushu Cancer CenterRecruiting

Fukuoka, Fukuoka 811-1395, Japan

Hokkaido University HospitalRecruiting

Sapporo, Hokkaidô 060-8648, Japan

Kanazawa University HospitalRecruiting

Kanazawa, Ishikawa-ken 9208641, Japan

Kagoshima University HospitalRecruiting

Kagoshima, Kagoshima-ken 890-8520, Japan

Kanagawa Cancer CenterRecruiting

Yokohama, Kanagawa 241-8515, Japan

Kyoto University HospitalRecruiting

Kyoto, Kyôto 606-8507, Japan

Mie University HospitalRecruiting

Tsu, Mie-ken 514-8507, Japan

Tohoku University HospitalRecruiting

Sendai, Miyagi 980-8574, Japan

Niigata University Medical and Dental HospitalRecruiting

Niigata, Niigata 951-8520, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer InstituteRecruiting

Osaka, Osaka 541-8567, Japan

The University of Tokyo HospitalRecruiting

Bunkyo-ku, Tokyo 113-8655, Japan

National Cancer Center HospitalRecruiting

Chuo-Ku, Tokyo 104-0045, Japan

The Cancer Institute Hospital of Japanese Foundation For Cancer ResearchRecruiting

Koto-Ku, Tokyo 135-8550, Japan

Kyorin University HospitalRecruiting

Mitaka-shi, Tokyo 181-8611, Japan

Yamaguchi University HospitalRecruiting

Ube-Shi, Yamaguchi 755-8505, Japan

Osaka University HospitalActive, not recruiting

Suita-Shi, Ôsaka 565-0871, Japan

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

Almada, 2805-267, Portugal

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

Coimbra, 3004-561, Portugal

Unidade Local de Saúde de São José - Hospital de Santo António dos CapuchosRecruiting

Lisbon, 1150-314, Portugal

Champalimaud Clinical CenterRecruiting

Lisbon, 1400-038, Portugal

Instituto Português de Oncologia Do Porto Francisco Gentil, EPERecruiting

Porto, 4200-072, Portugal

Hospital Oncologico, Puerto Rico Medical CenterRecruiting

Rio Piedras, 935, Puerto Rico

Spital Clinic Judetean de Urgenta BihorActive, not recruiting

Oradea, Bihor County 410169, Romania

Centrul De Oncologie "SF. Nectarie" S.R.L.Active, not recruiting

Craiova, Dolj 200542, Romania

Institutul Clinic FundeniWithdrawn

Bucharest, 22328, Romania

Centrul de Oncologie Euroclinic SRLActive, not recruiting

Iași, 700106, Romania

University Clinical Center of Serbia, Clinic for GastroenterohepatologyActive, not recruiting

Belgrade, 11000, Serbia

Military Medical Academy, Clinic for Gastroenterology and HepatologyActive, not recruiting

Belgrade, 11040, Serbia

Oncology Institute of Vojvodina, Internal Oncology ClinicWithdrawn

Kamenitz, 21204, Serbia

CHA Bundang Medical Center, CHA UniversityRecruiting

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

National Cancer CenterRecruiting

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

Seoul National University Bundang HospitalRecruiting

Seongnam-si, Gyeonggi-do 13620, South Korea

Pusan National University HospitalRecruiting

Busan, 49241, South Korea

Korea University Anam HospitalRecruiting

Seoul, 2841, South Korea

Seoul National University HospitalRecruiting

Seoul, 3080, South Korea

Severance Hospital, Yonsei University Health SystemRecruiting

Seoul, 3722, South Korea

Hanyang University Seoul HospitalWithdrawn

Seoul, 4763, South Korea

Asan Medical CenterRecruiting

Seoul, 5505, South Korea

Samsung Medical CenterRecruiting

Seoul, 6351, South Korea

Korea University Guro HospitalRecruiting

Seoul, 8308, South Korea

Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de SantiagoRecruiting

Santiago de Compostela, A Coruna 15706, Spain

Hospital Clinic de BarcelonaRecruiting

Barcelona, 08036, Spain

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

Barcelona, 8035, Spain

Hospital Universitario Reina SofiaRecruiting

Córdoba, 14004, Spain

Hospital Universitario Fundacion Jimenez DiazRecruiting

Madrid, 28040, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

Hospital Universitario La PazRecruiting

Madrid, 28048, Spain

Hospital Regional Universitario de MalagaRecruiting

Málaga, 29010, Spain

Clinica Universidad de NavarraRecruiting

Pamplona, 31008, Spain

Hospital Universitario Virgen MacarenaRecruiting

Seville, 41009, Spain

Hospital Universitario y Politecnico La FeActive, not recruiting

Valencia, 46026, Spain

Hospital Universitario Miguel ServetRecruiting

Zaragoza, 50009, Spain

Onkologiska mottagningen, Sahlgrenska UniversitetssjukhusetActive, not recruiting

Gothenburg, 413 45, Sweden

Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset HuddingeRecruiting

Huddinge, 14186, Sweden

Onkologiska mottagningen, Skånes Universitetssjukhus MalmöWithdrawn

Malmö, 205 02, Sweden

Kaohsiung Medical University - Chung-Ho Memorial HospitalRecruiting

Kaohsiung City, 807, Taiwan

Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical FoundationRecruiting

Kaohsiung City, 833, Taiwan

National Cheng Kung University HospitalRecruiting

Tainan, 704, Taiwan

National Taiwan University Cancer CenterRecruiting

Taipei, 106, Taiwan

Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical FoundationRecruiting

Taoyuan, 333, Taiwan

Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research CenterRecruiting

Istanbul, Fatih 34096, Turkey (Türkiye)

Hacettepe University Cancer InstituteRecruiting

Ankara, Sihhiye 06230, Turkey (Türkiye)

Akdeniz University Medical Faculty HospitalRecruiting

Antalya, 07070, Turkey (Türkiye)

Trakya University Faculty of MedicineRecruiting

Edirne, 22030, Turkey (Türkiye)

Mount Vernon Cancer CentreRecruiting

London, England HA 6 2RN, United Kingdom

NHS Foundation Trust Royal Marsden HospitalRecruiting

London, England SW3 6JJ, United Kingdom

The Christie NHS Foundation TrustRecruiting

Manchester, England M20 4BX, United Kingdom

Royal Marsden Hospital NHS Foundation TrustRecruiting

Surrey, England SM2 5PT, United Kingdom

Western General Hospital, Edinburgh Cancer CentreRecruiting

Edinburgh, Scotland EH4 2XU, United Kingdom