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Trial 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.

Acronym:

ZWI-ZW49-101

ACTRN/NCT /ethics:

NCT03821233

Scientific title:

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

Sponsor / Cooperative group:

Zymeworks Inc.

Trial & Patient Characteristics

Cancer TypeBreast, Stomach & Oesophageal
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Advanced, Metastatic or Widespread
Anticipated Start Date2019-04-15
Anticipated End Date2023-08-01

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlison Richards
EmailAlison.Richards@sa.gov.au
Phone08 8206 4835
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting