Clinical Trial

Experimental Treatment for Patients Receiving Chemotherapy

Study Description

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).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study Title

Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers

Clinical Trial ID

NCT02892123

ParticipAid ID

rb2rzb