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

ALX Oncology

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Higher Risk Myelodysplastic Syndromes

Treatments: Drug: evorpacept; Drug: azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04417517

AT148002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

evorpacept (ALX148) + azacitidine

Experimental group

Description:

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

Treatment:

Drug: azacitidine

Drug: evorpacept

azacitidine

Active Comparator group

Description:

Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

Treatment:

Drug: azacitidine