Clinical Trials /

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

NCT04417517

Description:

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04417517

Trial Eligibility

Document

Title

  • Brief Title: A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
  • Official Title: A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)

Clinical Trial IDs

  • ORG STUDY ID: AT148002
  • NCT ID: NCT04417517

Conditions

  • Higher Risk Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
evorpaceptALX148evorpacept (ALX148) + azacitidine
azacitidineVidazaazacitidine

Purpose

This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

Detailed Description

      The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with
      azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose
      of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of
      evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for
      patients with previously untreated higher risk MDS.

Trial Arms

NameTypeDescriptionInterventions
evorpacept (ALX148) + azacitidineExperimentalPhase 1: Participants will receive escalating doses of evorpacept (ALX148) in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle Phase 2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
  • evorpacept
  • azacitidine
azacitidineActive ComparatorPhase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
  • azacitidine

Eligibility Criteria

        Inclusion Criteria:

          -  Phase 1: Diagnosis of higher risk MDS that is either previously untreated or
             relapsed/refractory.

          -  Phase 2: Diagnosis of higher risk MDS that is previously untreated.

          -  Adequate renal and liver function.

          -  Age ≥18 years.

          -  Adequate performance status.

        Exclusion Criteria:

          -  Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.

          -  Prior treatment with any anti-CD47 or anti-SIRPα (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
  • MDS
  • CD47
  • Azacitidine
  • HMA
  • SIRP-alpha
  • evorpacept

Last Updated

August 25, 2021