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

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 09 Jul 2025

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At a glance

  • Drugs Zanidatamab (Primary)
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERIZON-BTC-01
  • Sponsors Zymeworks

Most Recent Events

  • 01 Jul 2025 According to the Jazz Pharmaceuticals media release, based on data from this trial, European Commission (EC) has granted conditional marketing authorization1 for Ziihera for the treatment of adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.
  • 30 May 2025 According to the Zymeworks media release, company announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). conditional approval based on the results of the HERIZON-BTC-01 clinical study.
  • 25 Apr 2025 According to Jazz Pharmaceuticals plc media release, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, based on data from this study. This recommendation will now be reviewed by the European Commission.

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