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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04755244
• Other study ID #: AT148005
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 5, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: ALX Oncology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: December 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
• venetoclax
BCL-2 inhibitor
• azacitidine
Hypomethylating agent (HMA)

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
ALX Oncology Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Dose Limiting Toxicities (DLT)	Number of participants with a DLT	Up to 28 days
Primary	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	Approximately 6 months