NCT04755244

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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. While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.

Conditions

• Acute Myeloid Leukemia
• AML, Adult

Interventions

Type	Name	Description
DRUG	evorpacept	Fusion protein that blocks CD47-SIRPalpha pathway
DRUG	venetoclax	BCL-2 inhibitor
DRUG	azacitidine	Hypomethylating agent (HMA)

Timeline

• Start date: 2021-05-05
• Primary completion: 2023-05-05
• Completion: 2023-08-16
• First posted: 2021-02-16
• Last updated: 2024-11-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study