Zanidatamab combined with standard therapy for advanced HER2-positive biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Zanidatamab in combination with Cisplatin and Gemcitabine, with the option of adding a PD-1/L1 inhibitor, as a first-line treatment for patients with advanced HER2-positive biliary tract cancer. Participants must have histologically confirmed biliary tract cancer that is locally advanced or metastatic and not eligible for curative treatments. The study aims to determine if this combination therapy improves outcomes compared to standard care alone.

Why it matters

Who can join: the full rules

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

Where it's running

• AdventHealth Hematology and Oncology
  Orlando, Florida, United States Recruiting
• Norton Cancer Institute - Audubon
  Louisville, Kentucky, United States Recruiting
• Oregon Health and Science University
  Portland, Oregon, United States Recruiting
• Centro de Investigaciónes Clínicas - Clínica Viedma
  Viedma, Río Negro Province, Argentina Recruiting
• Instituto Médico de la Fundación Estudios Clínicos
  Rosario, Santa Fe Province, Argentina Recruiting
• CAIPO Centro para la Atención Integral del Paciente Oncológico
  San Miguel de Tucumán, Tucumán Province, Argentina Recruiting

+135 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.