This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).
The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML. While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Fusion protein that blocks CD47-SIRPalpha pathway
BCL-2 inhibitor
Hypomethylating agent (HMA)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Phase 1: Dose Limiting Toxicities (DLT)
Number of participants with a DLT
Time frame: Up to 28 days
Phase 2: Composite complete remission rate (CRc)
Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Time frame: Approximately 6 months
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States