Myelodysplastic Syndrome Clinical Trial
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
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).
Full 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.
Eligibility Criteria
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).
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There are 14 Locations for this study
Los Angeles California, 90033, United States
Chicago Illinois, 60611, United States
Indianapolis Indiana, 46202, United States
Grand Rapids Michigan, 49546, United States
Rochester Minnesota, 55905, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Alicante , 03010, Spain
Cáceres , 10003, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
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