Status:
TERMINATED
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Lead Sponsor:
ALX Oncology Inc.
Conditions:
Higher Risk Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 comb...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04417517
Start Date
October 2 2020
End Date
June 10 2025
Last Update
July 20 2025
Active Locations (19)
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1
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
4
START Midwest
Grand Rapids, Michigan, United States, 49546