A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
Description
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.
Phase
N/AInclusion and Exclusion 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.
- Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.
- Prior treatment with any anti-CD47 or anti-SIRP
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.