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Clinical Trial Summary

This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety and tolerability of ZW49. Eligible patients include those with locally advanced (unresectable) or metastatic HER2-expressing cancers.


Clinical Trial Description

The study will use a 3+3 dose-escalation study design to evaluate the safety and tolerability of ZW49 and to determine the MTD or RD of ZW49 for further study. Selected expansion cohorts will be subsequently opened based upon Safety Monitoring Committee (SMC) recommendation and sponsor approval to further evaluate the safety and tolerability of ZW49 at the MTD or RD and to assess preliminary anti-tumor activity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03821233
Study type Interventional
Source Zymeworks Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 15, 2019
Completion date August 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02892123 - Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers Phase 1
Recruiting NCT05027139 - A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer Phase 1/Phase 2