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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALX Oncology Inc.
• Treatments: Azacitidine

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).