Spots Global Cancer Trial Database for A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
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Trial Identification
Brief Title: 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
Study ID: NCT03821233
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: 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-tumor activity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago Medicine, Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
NEXT Oncology, San Antonio, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Flinders Medical Centre, Adelaide, , Australia
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Joseph Woolery, PharmD, BCOP
Affiliation: Zymeworks BC Inc.
Role: STUDY_DIRECTOR
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