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Active, not recruitingNCT04675333Updated Aug 3, 2025

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

A Phase 2 interventional study of evorpacept and pembrolizumab in Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by ALX Oncology Inc.. Active, not recruiting at 44 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by ALX Oncology Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma

Keywords

  • ALX148
  • CD47
  • SIRPα
  • HNSCC
  • pembrolizumab
  • evorpacept
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
172 participants (actual)

Study arms

  • Experimental
    evorpacept (ALX148) + pembrolizumab + Chemotherapy

    evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.

    Drug: evorpacept · Drug: pembrolizumab · Drug: Cisplatin/Carboplatin; 5FU

  • Active comparator
    pembrolizumab + Chemotherapy

    pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.

    Drug: pembrolizumab · Drug: Cisplatin/Carboplatin; 5FU

Interventions

  • Drugevorpacept

    IV Q3W

    Also known as: ALX148

  • Drugpembrolizumab

    IV Q3W

    Also known as: KEYTRUDA®

  • DrugCisplatin/Carboplatin; 5FU

    IV Q3W

    Also known as: Platinol/Paraplatin; Adrucil

05

What researchers measure

Primary outcomes

  1. Objective response rate per RECIST 1.1

    Time frame: Last randomized patient reaching at least 24 weeks of follow-up

Secondary outcomes

  1. Duration of response

    Time frame: Up to 36 months

  2. Progression-free survival

    Time frame: Up to 36 months

  3. Overall survival

    Time frame: Up to 36 months

  4. Adverse events

    Time frame: Up to 36 months

06

Study locations

44 sites
  • Hoag Hospital
    Irvine, California 92618, United States
  • University of California San Diego
    La Jolla, California 92037, United States
  • Cedar Sinai Medical Center
    Los Angeles, California 90048, United States
  • University of Miami, Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • University of Maryland Medical System
    Baltimore, Maryland 21201, United States
  • Memorial Sloan Kettering
    New York, New York 10021, United States
  • The Ohio State University
    Columbus, Ohio 43235, United States
  • Oregon Health & Science University/ Knight Cancer Institute
    Portland, Oregon 97239, United States
  • Vanderbilt - Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Houston Methodist Cancer Center
    Houston, Texas 77030, United States
  • Royal Brisbane and Womens Hospital
    Herston, Queensland 4029, Australia
  • Ashford Cancer Centre
    Adelaide, South Australia 5037, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, 6009, Australia
  • Cliniques Universitaires Saint-Luc
    Brussels, Belgium
  • AZ Groeninge
    Kortrijk, 8500, Belgium
  • Amsterdam UMC, Locatie VUMC
    Amsterdam, 1081, Netherlands
  • Universitair Medisch Centrum Groningen
    Groningen, 9713, Netherlands
  • National University Cancer Institute
    Singapore, 119074, Singapore
  • National Cancer Centre Singapore
    Singapore, 168583, Singapore
  • Chungbuk National University Hospital
    Cheongju-si, 28644, South Korea
  • Yeungnam University Medical Center
    Daegu, 42415, South Korea
  • Gachon University (GCU) - Gil Medical Center (Gil Hospital)
    Incheon, 21565, South Korea
  • Seoul National University, Bundang Hospital
    Seongnam, 13620, South Korea
  • CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
    Seongnam-si, 13496, South Korea
  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
    Seoul, 03312, South Korea
  • Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
    Seoul, 07061, South Korea
  • Seoul National University Hospital
    Seoul, 3080, South Korea
  • Severance Hospital, Yonsei University Health System
    Seoul, 3722, South Korea
  • Samsung Medical Center
    Seoul, 6351, South Korea
  • Hospital Universitari Dexeus
    Barcelona, Barcelona 08028, Spain
  • Institut Catala d Oncologia (ICO)
    Badalona, 08916, Spain
  • Institut Catala dOncologia
    L'Hospitalet de Llobregat, 08908, Spain
  • Hospital Universitario Severo Ochoa
    Leganés, 28911, Spain
  • Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
    Madrid, 2850, Spain
  • Hospital Universitario La Paz
    Madrid, Spain
  • Hospital Regional Universitario de Malaga
    Málaga, 29011, Spain
  • Hospital Universitario de Navarra
    Pamplona, 31008, Spain
  • The Royal Marsden Hospital - Surrey
    London, 5PT, United Kingdom
  • University College London Hospital
    London, 5PT, United Kingdom
  • The Royal Marsden Hospital- London
    London, 6JJ, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04675333
Lead sponsor
ALX Oncology Inc.
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
May 10, 2021
Primary completion
Mar 3, 2025
Completion
Jun 30, 2026 (estimated)
Last update
Aug 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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