For Healthcare Professionals

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


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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).

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Acute Myeloid Leukemia,AML, Adult

Age (in years)



Phase 1/Phase 2

Participants needed


Est. Completion Date

Dec 31, 2023

Treatment type



ALX Oncology Inc. identifier


Study number


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