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

August 11, 2023 updated by: ALX Oncology Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

97

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Comprehensive Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: evorpacept (ALX148) + venetoclax + azacitidine

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
Drug: evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
Other Names:
  • ALX148
Drug: azacitidine
Hypomethylating agent (HMA)
Other Names:
  • Vidaza
Drug: venetoclax
BCL-2 inhibitor
Other Names:
  • Venclexta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Dose Limiting Toxicities (DLT)
Time Frame: Up to 28 days
Number of participants with a DLT
Up to 28 days
Phase 2: Composite complete remission rate (CRc)
Time Frame: Approximately 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALX Oncology Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

May 5, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT148005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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