ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies

Inclusion Criteria

• •Eligible subjects must meet all of the following criteria:
• •1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \[APL\]) or MDS per 2016 World Health Organization (WHO) criteria.
• •2. For AML (except for APL) cohort:
• •1. Previously treated relapsed/refractory AML subjects
• •3. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score \> 3 and bone marrow blasts ≥ 5%.
• •4. Subject must have a projected life expectancy of at least 12 weeks.
• •5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
• •6. Subject must have adequate liver function