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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04417517

Enrollment

Registered

2020-06-04

Start date

2020-10-02

Completion date

2025-06-10

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Higher Risk Myelodysplastic Syndromes

Keywords

ALX148, MDS, CD47, Azacitidine, HMA, SIRP-alpha, evorpacept, High risk

Brief summary

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.

Interventions

DRUGevorpacept

Fusion protein that blocks CD47-SIRPalpha pathway

DRUGazacitidine

Hypomethylating agent (HMA)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Phase 1: Dose Limiting Toxicities (DLT)	Up to 28 days	Number of participants with a DLT
Phase 1: Recommended Phase 2 Dose (RP2D)	Approximately 2 years	To identify the RP2D of ALX148 in combination with AZA
Phase 2: Complete response rate (CRR)	Approximately 6 months	Number of participants achieving a complete response per International Working Group (IWG) criteria

Countries

South Korea, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026