279
Participants
Start Date
September 30, 2016
Primary Completion Date
October 31, 2024
Study Completion Date
October 31, 2024
ZW25 (Zanidatamab)
ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:
Paclitaxel
Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4
Capecitabine
Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5
Vinorelbine
Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6
Tucatinib
Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7
Tucatinib
Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)
Seoul National University Bundang Hospital, Seongnam-si
University of Alabama, Birmingham
Sarah Cannon - Tennessee Oncology, Nashville
Rush University Medical Center, Chicago
MD Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics (START), San Antonio
University of Colorado Cancer Center, Aurora
USC/Norris Cancer Center, Los Angeles
Hoag Family Cancer Institute, Newport Beach
Northwest Medical Specialties, Tacoma
University of Ottawa, Ottawa
Princess Margaret Cancer Centre, Toronto
Jewish General Hospital, Montreal
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY