NCT04675294

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Detailed description

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	evorpacept	IV Q3W
DRUG	pembrolizumab	IV Q3W

Timeline

• Start date: 2021-04-02
• Primary completion: 2025-03-03
• Completion: 2026-06-30
• First posted: 2020-12-19
• Last updated: 2025-08-01

Locations

53 sites across 9 countries: United States, Australia, Belgium, Canada, Netherlands, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study