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 promyelocyticleukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.

2. For AML (except for APL) cohort:

3. Previously treated relapsed/refractory AML subjects

4. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and <60years will be eligible if the subject has at least one of the followingco-morbidities, which make the subject unfit for intensive chemotherapy

5. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic ScoringSystem (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.

6. Subject must have a projected life expectancy of at least 12 weeks.

7. 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 bythe Cockcroft-Gault formula.

8. Subject must have adequate liver function

Exclusion Criteria:

1. R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.

2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .

3. Subject has known central nervous system (CNS) leukemia.

4. Suggest patients with active hepatitis B or C virus infection

5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV)antibody test.

6. Subjects have another active malignancy within the past 2 years before study entry,except for curatively treated.