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

Last updated: July 30, 2025
Sponsor: ALX Oncology Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lung Cancer

Head And Neck Cancer

Carcinoma

Treatment

evorpacept

Cisplatin/Carboplatin; 5FU

pembrolizumab

Clinical Study ID

NCT04675333
AT148004
KEYNOTE-B88
2023-508342-17-00
MK-3475-B88
2020-004662-19
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previously untreated metastatic or unresectable, recurrent head and neck squamouscell carcinoma.

  • Adequate bone marrow function.

  • Adequate renal and liver function.

  • Adequate ECOG performance status.

Exclusion

Exclusion Criteria:

  • Patients with known symptomatic CNS metastases or leptomeningeal disease requiringsteroids.

  • History of (non-infectious) pneumonitis that required steroids or currentpneumonitis.

  • Prior treatment with any anti-CD47 or anti-SIRPα agent.

  • Prior treatment with anti-PD-1 or PD-L1.

Study Design

Total Participants: 172
Treatment Group(s): 5
Primary Treatment: evorpacept
Phase: 2
Study Start date:
May 10, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Royal Brisbane and Womens Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Ashford Cancer Centre

    Adelaide, South Australia 5037
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, 6009
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles,
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Gachon University (GCU) - Gil Medical Center (Gil Hospital)

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Seoul National University, Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)

    Seongnam-si, 13496
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, 1081
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713
    Netherlands

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • National University Cancer Institute

    Singapore, 119074
    Singapore

    Site Not Available

  • Institut Catala d Oncologia (ICO)

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Universitari Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • Institut Catala dOncologia

    L'Hospitalet De Llobregat, 08908
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, 28911
    Spain

    Site Not Available

  • Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent

    Madrid, 2850
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Málaga, 29011
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • The Royal Marsden Hospital - Surrey

    London, 5PT
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital- London

    London, 6JJ
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, 5PT
    United Kingdom

    Site Not Available

  • Hoag Hospital

    Irvine, California 92618
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Cedar Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Maryland Medical System

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10021
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Oregon Health & Science University/ Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Houston Methodist Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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