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

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.

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-SIRPα agent.
• Prior treatment with anti-PD-1 or PD-L1.