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

NCT04675294 · tracked via the Priya Life Science UK tracker

Sponsor

ALX Oncology Inc.

Phase

Phase 2

Started

2021-04-02

Last updated

2025-08-01

Condition(s) studied

Head and Neck CancerHead and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

evorpaceptpembrolizumab

evorpacept: IV Q3W

pembrolizumab: IV Q3W

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (53)

Facility	City	Region
Hoag Hospital	Irvine	California
University of California San Diego	La Jolla	California
H. Lee Moffitt Cancer Center	Tampa	Florida
Northwest Georgia Oncology Centers	Marietta	Georgia
Rush University Medical Center	Chicago	Illinois
Blessing Cancer Center	Quincy	Illinois
University of Maryland Medical System	Baltimore	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Rutgers Cancer Institute of New Jersey	Newark	New Jersey
Memorial Sloan-Kettering Cancer Center	Long Island City	New York
The Ohio State University	Columbus	Ohio
Oregon Health & Science University	Portland	Oregon
Vanderbilt - Ingram Cancer Center	Nashville	Tennessee
Houston Methodist Cancer Center	Houston	Texas
St. Vincent's	Sydney	New South Wales
Royal Brisbane and Womens Hospital	Brisbane	Queensland
Peter MacCallum Cancer Centre	Melbourne	Victoria
Sir Charles Gairdner Hospital	Perth	Western 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
LHSC - Victoria Hospital	London	Ontario
Ottawa Hospital Cancer Centre	Ottawa	Ontario
Princess Margaret Cancer Centre	Toronto	Ontario
VUMC Goederenontvangst	Amsterdam	Netherlands
Universitair Medisch Centrum Groningen	Groningen	Netherlands
National University Cancer Institute	Singapore	Singapore
National Cancer Centre Singapore	Singapore	Singapore
Chungbuk National University Hospital	Cheongju-si	South Korea
Yeungnam University Medical Center	Daegu	South Korea
Chungnam National University Hospital	Daejeon	South Korea
CHA University of Bundang	Gyeonggi-do	South Korea
Gachon University - Gil Medical Center	Incheon	South Korea
Seoul National University Bundang Hospital	Seongnam	South Korea
Korea University Medical Center (KUMC) - Korea University Anam Hospital	Seoul	South Korea
Seoul National University Hospital	Seoul	South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital	Seoul	South Korea
Samsung Medical Center	Seoul	South Korea

+ 13 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More ALX Oncology Inc. trials in the UK

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Active, not recruiting

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer Recruiting

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) Active, not recruiting

Other trials for the same condition

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2) Active, not recruiting

Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 Active, not recruiting

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Active, not recruiting

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone Active, not recruiting

To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04675294 on ClinicalTrials.gov ↗ ← All trials in the UK