Overview

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

Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
Summary
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ALX Oncology Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab
Criteria
Inclusion Criteria:

- Patients with metastatic or unresectable, recurrent head and neck squamous cell
carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior
systemic therapy for their advanced disease.

- Adequate bone marrow function.

- Adequate renal and liver function.

- Adequate ECOG performance status.

Exclusion Criteria:

- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring
steroids.

- History of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.

- Prior treatment with any anti-CD47 or anti-SIRPĪ± agent.

- Prior treatment with anti-PD-1 or PD-L1.