A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

Inclusion Criteria:

1. Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification.
2. Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy.
3. Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen.
4. Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy.
5. Adequate renal and liver function.
6. Age ≥18 years.
7. Adequate performance status.

Exclusion Criteria:

1. In Phase 1a and 1b, patients that have undergone prior allo-HSCT must be at least 3 months post-HSCT, without uncontrolled graft-versus-host disease (GVHD). For Phase 2, patients that have undergone prior allo-HSCT are excluded.
2. Patients with newly diagnosed AML with favorable risk cytogenetics such as t(8;21), inv(16), or t(16;16) as per the NCCN Guidelines Version 3, 2019 for AML.
3. Patients with acute promyelocytic leukemia (APL).
4. Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent.
5. 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).