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

Running, not enrolling · Phase 2

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

In brief

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

Key facts

Study ID

NCT04675294

Run by

ALX Oncology Inc.

People needed

189

Starts

2021-04-02

Expected to finish

2026-06-30

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California San Diego — La Jolla, California, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Northwest Georgia Oncology Centers — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Blessing Cancer Center — Quincy, Illinois, United States
• University of Maryland Medical System — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Rutgers Cancer Institute of New Jersey — Newark, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — Long Island City, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
• Houston Methodist Cancer Center — Houston, Texas, United States
• St. Vincent's — Sydney, New South Wales, Australia
• Royal Brisbane and Womens Hospital — Brisbane, Queensland, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
• Ashford Cancer Centre Research — Windsor Gardens, Australia
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• AZ Groeninge — Kortrijk, Belgium
• UZ Leuven — Leuven, Belgium
• Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Ontario, Canada
• LHSC - Victoria Hospital — London, Ontario, Canada
• Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
• Hoag Hospital — Irvine, California, United States

Full record on ClinicalTrials.gov

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