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

NCT04466891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-09-15

Study results available
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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

DRUG

ZW25 (Zanidatamab)

Administered intravenously

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Jazz Pharmaceuticals Ireland Limited

    collaborator INDUSTRY

  • BeOne Medicines LTD

    collaborator UNKNOWN

  • Jazz Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-07-28
Completion
2024-07-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Chile
  • China
  • France
  • Italy
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466891 on ClinicalTrials.gov