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

Status: administratively complete

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).

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).

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.

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

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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