A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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:

* 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).

Additional Trial Information

Phase 1/2

Enrollment: 173 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

Illinois

Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

Michigan

START Midwest Midwest

Grand Rapids, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Washington

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Open and Accepting
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