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

ALX Oncology

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: AML, Adult; Acute Myeloid Leukemia

Treatments: Drug: venetoclax; Drug: azacitidine; Drug: evorpacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT04755244

AT148005

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 97 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

97 participants in 1 patient group

evorpacept (ALX148) + venetoclax + azacitidine

Experimental group

Description:

Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine

Treatment:

Drug: azacitidine

Drug: evorpacept

Drug: venetoclax