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

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.

NCT Number	NCT06282575
Lead Sponsor	Jazz Pharmaceuticals
Conditions	Biliary Tract Cancer
Enrollment	286 participants
Start Date	2024-07-19
Primary Completion	2028-12-01 (estimated)
Study Completion	2030-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14