Myelodysplastic Syndrome Clinical Trial

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

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).

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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.

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Eligibility Criteria

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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

173

Study ID:

NCT04417517

Recruitment Status:

Recruiting

Sponsor:

ALX Oncology Inc.

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There are 8 Locations for this study

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Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
IU Simon Cancer Center
Indianapolis Indiana, 46202, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul Saint Mary's Hospital
Seoul , , Korea, Republic of
Severance Hospital
Seoul , , Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

173

Study ID:

NCT04417517

Recruitment Status:

Recruiting

Sponsor:


ALX Oncology Inc.

How clear is this clinincal trial information?

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