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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALX Oncology Inc.
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification.

• Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy.

• Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen.

• Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy.

• Adequate renal and liver function.

• Age ≥18 years.

• Adequate performance status.

Exclusion Criteria:

• 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.

• 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.

• Patients with acute promyelocytic leukemia (APL).

• Prior treatment with any anti-CD47 or anti-SIRPalpha (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).