NCT06282575

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-07-19
• Primary completion: 2028-12-01
• Completion: 2030-04-01
• First posted: 2024-02-28
• Last updated: 2026-03-24

Locations

184 sites across 25 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, India, Israel, Italy, Japan, Portugal, Puerto Rico, Romania, Serbia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study