“Trial of ZW25 in Patients With Advanced HER2-expressing Cancers”
This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-expressing cancers. This study will also the evaluate the way the body absorbs, distributes, and eliminates ZW25 (pharmacokinetics or PK).
Drug - ZW25
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 selected chemotherapy agents.
Combination Product - Paclitaxel
Part 3, Treatment Group 1 chemotherapy combination
Combination Product - Capecitabine
Part 3, Treatment Group 2 chemotherapy combination
Combination Product - Vinorelbine
Part 3, Treatment Group 3 chemotherapy combination
Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers