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

Sponsor
ALX Oncology Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04755244
Collaborator
(none)
97
5
1
30.9
19.4
0.6

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
97 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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: venetoclax
    BCL-2 inhibitor
    Other Names:
  • Venclexta
  • Drug: azacitidine
    Hypomethylating agent (HMA)
    Other Names:
  • Vidaza
  • Outcome Measures

    Primary Outcome Measures

    1. Phase 1: Dose Limiting Toxicities (DLT) [Up to 28 days]

      Number of participants with a DLT

    2. Phase 2: Composite complete remission rate (CRc) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    2 Roswell Park Comprehensive Cancer Center Buffalo New York United States 14263
    3 Duke University Medical Center Durham North Carolina United States 27710
    4 Vanderbilt University Medical Center Nashville Tennessee United States 37203
    5 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • ALX Oncology Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALX Oncology Inc.
    ClinicalTrials.gov Identifier:
    NCT04755244
    Other Study ID Numbers:
    • AT148005
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ALX Oncology Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022