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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Fusion protein that blocks CD47-SIRPalpha pathway
Hypomethylating agent (HMA)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Phase 1: Dose Limiting Toxicities (DLT)
Number of participants with a DLT
Time frame: Up to 28 days
Phase 1: Recommended Phase 2 Dose (RP2D)
To identify the RP2D of ALX148 in combination with AZA
Time frame: Approximately 2 years
Phase 2: Complete response rate (CRR)
Number of participants achieving a complete response per International Working Group (IWG) criteria
Time frame: Approximately 6 months
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