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

Last updated: March 21, 2025
Sponsor: ALX Oncology Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Human Papilloma Virus (Hpv)

Carcinoma

Head And Neck Cancer

Treatment

Evorpacept

pembrolizumab

evorpacept

Clinical Study ID

NCT04675294
AT148003
2020-004093-21
2023-508340-22-00
MK-3475-B87
KEYNOTE-B87
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with metastatic or unresectable, recurrent head and neck squamous cellcarcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received priorsystemic therapy for their advanced disease.

  • 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 has currentpneumonitis.

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

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

Study Design

Total Participants: 189
Treatment Group(s): 4
Primary Treatment: Evorpacept
Phase: 2
Study Start date:
April 02, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • St. Vincent's

    Sydney, New South Wales 2146
    Australia

    Site Not Available

  • Royal Brisbane and Womens Hospital

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Ashford Cancer Center

    Adelaide, South Australia 5037
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3051
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Ashford Cancer Centre Research

    Windsor Gardens, 5087
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles,
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, B - 3000
    Belgium

    Site Not Available

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario L9G2X1
    Canada

    Site Not Available

  • LHSC - Victoria Hospital

    London, Ontario N6A5W9
    Canada

    Site Not Available

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario
    Canada

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • CHA University of Bundang

    Gyeonggi-do, 13496
    Korea, Republic of

    Site Not Available

  • Gachon University - Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Korea University Medical Center (KUMC) - Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • SNU Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University

    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

  • Catholic University of Korea, St. Vincent's Hospital Suwon

    Suwon, 16247
    Korea, Republic of

    Site Not Available

  • Yonsei University - Wonju Severance Christian Hospital

    Wŏnju, 26426
    Korea, Republic of

    Site Not Available

  • VUMC Goederenontvangst

    Amsterdam, 1081
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713
    Netherlands

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 169610
    Singapore

    Site Not Available

  • National University Cancer Institute

    Singapore, 119074
    Singapore

    Site Not Available

  • Hospital Universitari Dexeus

    Barcelona, 08028
    Spain

    Site Not Available

  • Institud Catala d´Oncologia

    Barcelona, 08908
    Spain

    Site Not Available

  • HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Severo Ochoa

    Madrid, 28911
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 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

  • H. Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Blessing Cancer Center

    Quincy, Illinois 62301
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland Medical System

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    Long Island City, New York 11101
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    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

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.