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

NCT04755244

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
  • 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 IDs

  • ORG STUDY ID: AT148005
  • NCT ID: NCT04755244

Conditions

  • Acute Myeloid Leukemia
  • AML, Adult

Interventions

DrugSynonymsArms
evorpaceptALX148evorpacept (ALX148) + venetoclax + azacitidine
venetoclaxVenclextaevorpacept (ALX148) + venetoclax + azacitidine
azacitidineVidazaevorpacept (ALX148) + venetoclax + azacitidine

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
evorpacept (ALX148) + venetoclax + azacitidineExperimentalPhase 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
  • evorpacept
  • venetoclax
  • azacitidine

Eligibility Criteria

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Dose Limiting Toxicities (DLT)
Time Frame:Up to 28 days
Safety Issue:
Description:Number of participants with a DLT

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ALX Oncology Inc.

Trial Keywords

  • ALX148
  • CD47
  • SIRPalpha
  • azacitidine
  • venetoclax
  • evorpacept

Last Updated

August 25, 2021