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

AT148002

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).

2020-10-02

2023-12-31

2024-06-30

Active (not recruiting)

Early phase I

65

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}

2023-08-14