Benzinga | May 10, 2021 07:05AM EDT

ALX Oncology Announces First Patient Dosed in ASPEN-03, a Phase 2 Study of ALX148 in Combination with KEYTRUDA for the Treatment of Patients with Advanced Head and Neck Squamous Cell Carcinoma

ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA(r) (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").



ASPEN-03 (NCT04675294) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 plus pembrolizumab in patients with first line metastatic or unresectable, recurrent PD-L1 positive HNSCC. This study is being conducted in collaboration with Merck and is based upon promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148's Fast Track designation in HNSCC granted by the U.S. Food and Drug Administration.