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RECRUITING

NCT06282575

PHASE3

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

View on ClinicalTrials.gov

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 line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2024-07-19

Completion Date

2030-04-01

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Biliary Tract Cancer

Interventions

DRUG

Zanidatamab

Administered intravenously (IV)

DRUG

Cisplatin

Administered intravenously (IV)

DRUG

Gemcitabine

Administered intravenously (IV)

DRUG

Pembrolizumab

Administered intravenously (IV)

DRUG

Durvalumab

Administered intravenously (IV)

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

Locations (185)

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)