NCT03821233

A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers

A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Zymeworks BC Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HER2-expressing Cancers

Interventions

Type	Name	Description
DRUG	ZW49	* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC * Expansion: MTD or RD identified in the dose-escalation part of the study

Timeline

• Start date: 2019-04-15
• Primary completion: 2024-09-27
• Completion: 2024-10-08
• First posted: 2019-01-29
• Last updated: 2025-01-29

Locations

16 sites across 4 countries: United States, Australia, Canada, South Korea

Regulatory

• FDA-regulated drug study