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)

• 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