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

Recruiting now · Phase 3

Conditions studied: Biliary Tract Cancer

In brief

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.

Key facts

Study ID

NCT06282575

Run by

Jazz Pharmaceuticals

People needed

286

Starts

2024-07-19

Expected to finish

2030-04-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Imelda VZW — Bonheiden, Antwerpen, Belgium (enrolling)
• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)
• Centro Médico en Oncología Clínica EXELSUS S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Centro Médico Privado CEMAIC — Córdoba, Argentina (enrolling)
• AdventHealth Hematology and Oncology — Orlando, Florida, United States (enrolling)
• UZ Antwerpen — Edegem, Antwerpen, Belgium (enrolling)
• Instituto Médico de la Fundación Estudios Clínicos — Rosario, Santa Fe Province, Argentina (enrolling)
• CAIPO Centro para la Atención Integral del Paciente Oncológico — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• City of Hope(City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States (enrolling)
• Norton Cancer Institute - Audubon — Louisville, Kentucky, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Centers — New York, New York, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Saint Francis Cancer Center — Greenville, South Carolina, United States (enrolling)
• Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• The Univerrsity of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Virginia Commonwealth University, VCU Health — Richmond, Virginia, United States (enrolling)
• Hospital Italiano de Buenos Aires — Ciudad Autónoma de Buenos Aires (caba), Buenos Altes, Argentina (enrolling)
• Fundación ARS Médica — San Salvador de Jujuy, Jujuy Province, Argentina (enrolling)
• Centro de Investigaciónes Clínicas - Clínica Viedma — Viedma, Río Negro Province, Argentina (enrolling)
• Hospital Provincial Del Centenario — Rosario, Santa Fe Province, Argentina (enrolling)
• Liga Norte Riograndense Contra O Cancer — Natal, Rio Grande do Norte, Brazil (enrolling)

Full record on ClinicalTrials.gov

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