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

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.