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

Stopped early · Phase 1

Conditions studied: Higher Risk Myelodysplastic Syndromes

In brief

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).

Key facts

Study ID

NCT04417517

Run by

ALX Oncology Inc.

People needed

65

Starts

2020-10-02

Expected to finish

2025-06-10

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.