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TerminatedNCT04417517Updated Jul 20, 2025

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

A Phase 1 interventional study of evorpacept and azacitidine in Higher Risk Myelodysplastic Syndromes, sponsored by ALX Oncology Inc.. Terminated at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by ALX Oncology Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
While intended to be a Phase 1/2 clinical study, the study did not proceed to Phase 2.

From the registry’s dates

  • Primary completion was Jan 2025, 1 year 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

Read the detailed description

The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.

02

Conditions studied

  • Higher Risk Myelodysplastic Syndromes

Keywords

  • ALX148
  • MDS
  • CD47
  • Azacitidine
  • HMA
  • SIRP-alpha
  • evorpacept
  • High risk
03

In context

Lead sponsor

ALX Oncology Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Phase 1: Diagnosis of higher risk MDS that is either previously untreated or relapsed/refractory.
  • Phase 2: Diagnosis of higher risk MDS that is previously untreated.
  • Adequate renal and liver function.
  • Age ≥18 years.
  • Adequate performance status.

Exclusion criteria

Exclusion Criteria:

  • Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.
  • Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
  • Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    evorpacept (ALX148) + azacitidine

    Phase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

    Drug: evorpacept · Drug: azacitidine

  • Active comparator
    azacitidine

    Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

    Drug: azacitidine

Interventions

  • Drugevorpacept

    Fusion protein that blocks CD47-SIRPalpha pathway

    Also known as: ALX148

  • Drugazacitidine

    Hypomethylating agent (HMA)

    Also known as: Vidaza

06

What researchers measure

Primary outcomes

  1. Phase 1: Dose Limiting Toxicities (DLT)

    Number of participants with a DLT

    Time frame: Up to 28 days

  2. Phase 1: Recommended Phase 2 Dose (RP2D)

    To identify the RP2D of ALX148 in combination with AZA

    Time frame: Approximately 2 years

  3. Phase 2: Complete response rate (CRR)

    Number of participants achieving a complete response per International Working Group (IWG) criteria

    Time frame: Approximately 6 months

07

Study locations

19 sites
  • University of Southern California, Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • IU Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • START Midwest
    Grand Rapids, Michigan 49546, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37203, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
  • Asan Medical Center
    Seoul, South Korea
  • Samsung Medical Center
    Seoul, South Korea
  • Seoul National University Hospital
    Seoul, South Korea
  • Seoul Saint Mary's Hospital
    Seoul, South Korea
  • Severance Hospital
    Seoul, South Korea
  • Hospital General Universitario de Alicante
    Alicante, 03010, Spain
  • Hospital San Pedro de Alcantara
    Cáceres, 10003, Spain
  • Hospital Universitario de Salamanca
    Salamanca, 37007, Spain
  • Hospital Universitari i Politecnic La Fe de Valencia
    Valencia, 46026, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04417517
Lead sponsor
ALX Oncology Inc.
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
Oct 2, 2020
Primary completion
Jan 17, 2025
Completion
Jun 10, 2025
Last update
Jul 20, 2025

Oversight

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

Not currently enrolling

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

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