NCT04466891

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

Conditions

• HER2-amplified Biliary Tract Cancers

Interventions

Type	Name	Description
DRUG	ZW25 (Zanidatamab)	Administered intravenously

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-07-28
• Completion: 2024-07-11
• First posted: 2020-07-10
• Last updated: 2025-09-15
• Results posted: 2024-08-21

Locations

67 sites across 9 countries: United States, Canada, Chile, China, France, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study