NCT04417517

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Higher Risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	evorpacept	Fusion protein that blocks CD47-SIRPalpha pathway
DRUG	azacitidine	Hypomethylating agent (HMA)

Timeline

• Start date: 2020-10-02
• Primary completion: 2025-01-17
• Completion: 2025-06-10
• First posted: 2020-06-04
• Last updated: 2025-07-20

Locations

19 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study