NCT02892123

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) 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).

Detailed description

Part 1 of the study will evaluate increasing doses of ZW25 to find the highest dose of ZW25 that does not cause unacceptable side effects (maximum-tolerated dose or MTD), the lowest safe dose with the highest rate of effectiveness (optimal biological dose or OBD), and/or other recommended dosages (RDs) of ZW25 in up to 7 dose-specific cohorts. Eligible patients include those with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy). Part 2 of the study will further evaluate the safety, tolerability, and efficacy of ZW25 in patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after receipt of all therapies known to confer clinical benefit (or ineligible to receive therapy) in up to 5 separate disease-specific cohorts. Part 3 of the study will evaluate the safety, tolerability, and efficacy of ZW25 combined with selected chemotherapy agents, including paclitaxel, capecitabine, vinorelbine, or capecitabine and tucatinib. Patients with selected HER2-expressing locally advanced (unresectable) and/or metastatic cancers that have progressed after at least 1 and no more than 3 prior systemic chemotherapy regimens will be evaluated in this part of the study.

Conditions

• HER2-expressing Cancers

Interventions

Type	Name	Description
DRUG	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:
DRUG	Paclitaxel	Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4
DRUG	Capecitabine	Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5
DRUG	Vinorelbine	Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6
DRUG	Tucatinib	Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7
DRUG	Tucatinib	Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)

Timeline

• Start date: 2016-09-30
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2016-09-08
• Last updated: 2024-11-27

Locations

17 sites across 3 countries: United States, Canada, South Korea