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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
evorpacept (ALX148) + azacitidine
Phase 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
  • Drug: evorpacept
    Fusion protein that blocks CD47-SIRPalpha pathway
    Other names:
    • ALX148
  • Drug: azacitidine
    Hypomethylating agent (HMA)
    Other names:
    • Vidaza
Active Comparator
azacitidine
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
  • Drug: evorpacept
    Fusion protein that blocks CD47-SIRPalpha pathway
    Other names:
    • ALX148
  • Drug: azacitidine
    Hypomethylating agent (HMA)
    Other names:
    • Vidaza

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
ALX Oncology Inc.

Study Contact

Abraham Fong, MD, PhD
(650)466-7125
info@alxoncology.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.