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.
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Incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 4 weeks
Incidence of adverse events
Timeframe: Up to 7 months
Incidence of lab abnormalities
Timeframe: Up to 7 months
Incidence of electrocardiogram (ECG) and left ventricular ejection fraction (LVEF) abnormalities
Timeframe: Up to 7 months
Incidence of dose reductions of ZW49
Timeframe: Up to 7 months