A PHASE 1 DOSE ESCALATION STUDY OF DS-3032B, AN ORAL MDM2 INHIBITOR, AS SINGLE AGENT AND IN COMBINATION WITH 5-AZACITIDINE IN SUBJECTS WITH ACUTE MYELOGENOUS LEUKEMIA (AML) OR HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS)
This study will take place in parts: - Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules - Dose Escalation (Part 1A): Participants receive milademetan in combination with AZA, with different dose schedules The recommended dose for Part 2 will be selected. - Dose Expansion (Part 2): After Part 1A, participants will receive the recommended Part 2 dose schedule. There will be three groups - those with: 1. refractory or relapsed AML 2. newly diagnosed AML unfit for intensive chemotherapy 3. high-risk MDS - End-of-Study Follow-Up: Safety information will be collected until 30 days after the last treatment. This is the end of the study. The recommended dose for the next study will be selected.