A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
NCT ID: NCT04417517
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
65 participants
INTERVENTIONAL
2020-10-02
2025-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
azacitidine
Hypomethylating agent (HMA)
azacitidine
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
azacitidine
Hypomethylating agent (HMA)
Interventions
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evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
azacitidine
Hypomethylating agent (HMA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phase 2: Diagnosis of higher risk MDS that is previously untreated.
* Adequate renal and liver function.
* Age ≥18 years.
* Adequate performance status.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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ALX Oncology Inc.
INDUSTRY
Responsible Party
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Locations
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University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
IU Simon Cancer Center
Indianapolis, Indiana, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 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, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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AT148002
Identifier Type: -
Identifier Source: org_study_id
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