NCT05027139

A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer

A Phase 1b/2, 2-part Open-label Study to Assess the Safety and Antitumor Activity of Zanidatamab in Combination With ALX148 in Advanced HER2-expressing Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced \[inoperable\] and/or metastatic) human epidermal growth factor receptor 2 (HER2)-expressing cancer.

Detailed description

Part 1 of the study will first evaluate the safety and tolerability and establish the recommended doses (RDs) of zanidatamab in combination with evorpacept (ALX148). Part 2 of the study will evaluate the anti-tumor activity of the combination of zanidatamab plus evorpacept (ALX148) at the RD levels in indication-specific expansion cohorts.

Conditions

• HER2-expressing Cancers

Interventions

Type	Name	Description
DRUG	Zanidatamab	Administered intravenously (IV)
DRUG	Evorpacept	Administered IV

Timeline

• Start date: 2021-09-15
• Primary completion: 2025-07-07
• Completion: 2025-09-30
• First posted: 2021-08-30
• Last updated: 2025-10-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study