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

Official Title

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

Summary:

This multicentre, open-label, single-arm trial will evaluate the anti-tumour 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).

Trial Description

Primary Outcome:

  • Confirmed objective response rate (ORR) by independent central review (ICR)
Secondary Outcome:
  • Duration of response (DOR) by ICR
  • DOR at ≥ 16 weeks by ICR
  • Disease control rate (DCR) by ICR
  • Progression-free survival (PFS) by ICR
  • ORR by investigator assessment
  • DOR by investigator assessment
  • DOR at ≥ 16 weeks by investigator assessment
  • DCR by investigator assessment
  • PFS by investigator assessment
  • Overall survival
  • Incidence of adverse events (AEs)
  • Incidence of laboratory abnormalities
  • Maximum serum concentration of ZW25
  • Trough concentration of ZW25
  • Incidence of anti-drug antibodies (ADAs)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society