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

Phase 2

Active, not recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer
• Interventions: Drug: evorpacept; Drug: pembrolizumab

• Registration Number: NCT04675294
• Lead Sponsor: ALX Oncology Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Study Start: 2021-04-02
• Primary Completion: 2025-03-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
evorpacept (ALX148) + pembrolizumab	pembrolizumab	evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
pembrolizumab	pembrolizumab	pembrolizumab 200 mg IV given every 3 weeks.
evorpacept (ALX148) + pembrolizumab	evorpacept	evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.

Primary Outcome Measures

Name	Time	Method
Objective response rate per RECIST 1.1	Last randomized patient reaching at least 24 weeks of follow-up

Secondary Outcome Measures

Name	Time	Method
Duration of response	Up to 36 months
Progression-free survival	Up to 36 months
Overall survival	Up to 36 months
Adverse events	Up to 36 months

Trial Locations

Locations (52)

Hoag Hospital; 🇺🇸 Irvine, California, United States

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

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