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

Higher Risk Myelodysplastic Syndromes Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04417517
• Other study ID #: AT148002
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: ALX Oncology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-SIRPa (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).

Related Conditions & MeSH terms

• Higher Risk Myelodysplastic Syndromes
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
• azacitidine
Hypomethylating agent (HMA)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital San Pedro de Alcantara	Cáceres
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	START Midwest	Grand Rapids	Michigan
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	IU Simon Cancer Center	Indianapolis	Indiana
United States	University of Southern California, Norris Comprehensive Cancer Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ALX Oncology Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Dose Limiting Toxicities (DLT)	Number of participants with a DLT	Up to 28 days
Primary	Phase 2: Complete response rate (CRR)	Number of participants achieving a complete response per International Working Group (IWG) criteria	Approximately 6 months