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

Official Title

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

Summary:

This is a first-in-human, Phase 1, multicentre, 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.

Trial Description

Primary Outcome:

• Incidence of dose-limiting toxicities (DLTs)
• Incidence of adverse events
• Incidence of lab abnormalities
• Incidence of electrocardiogram (ECG) and left ventricular ejection fraction (LVEF) abnormalities
• Incidence of dose reductions of ZW49

Secondary Outcome:

• Serum concentrations of ZW49
• Incidence of anti-drug antibodies (ADAs)
• Objective response rate (ORR)
• Disease control rate
• Duration of response
• Progression-free survival
• Overall survival

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-tumour activity.

View this trial on ClinicalTrials.gov