Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Phase 2

Active, not recruiting

• Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: pembrolizumab; Drug: evorpacept; Drug: Cisplatin/Carboplatin; 5FU

• Registration Number: NCT04675333
• Lead Sponsor: ALX Oncology Inc.

Brief Summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy 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 + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2021-05-10
• Primary Completion: 2025-03-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
• 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 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 + Chemotherapy	Cisplatin/Carboplatin; 5FU	evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
pembrolizumab + Chemotherapy	pembrolizumab	pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
pembrolizumab + Chemotherapy	Cisplatin/Carboplatin; 5FU	pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
evorpacept (ALX148) + pembrolizumab + Chemotherapy	pembrolizumab	evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
evorpacept (ALX148) + pembrolizumab + Chemotherapy	evorpacept	evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy 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
Progression-free survival	Up to 36 months
Overall survival	Up to 36 months
Adverse events	Up to 36 months
Duration of response	Up to 36 months

Trial Locations

Locations (44)

Hoag Hospital; 🇺🇸 Irvine, California, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Cedar Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Miami, Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Maryland Medical System; 🇺🇸 Baltimore, Maryland, United States

Memorial Sloan Kettering; 🇺🇸 New York, New York, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

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