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.
Powered by
SC CTSI