Vanderbilt Clinical Trials

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

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

Higher Risk Myelodysplastic Syndromes

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

Arm	Description	Assigned 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

More Details

Status: Active, not recruiting
Sponsor: ALX Oncology Inc.

Study Contact

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.