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Clinical Trial 20159
Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03821233
Phase: Phase I
Prinicipal Investigator: Heather Han
Study 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, 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.
Objective
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.
Therapies
Medications
ZW49 ()
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