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A Phase 1 Study of ZW49 in Patients with Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers
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.
primary: To determine the maximum tolerated dose (MTD)/recommended dose (RD) of ZW49; To characterize the safety and tolerability of ZW49. secondary: To evaluate the pharmacokinetics (PK) of ZW49; To evaluate the immunogenicity of ZW49; To evaluate the anti-tumor activity of ZW49 in human epidermal growth factor receptor 2 (HER2)-expressing cancers.