Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML

Inclusion criteria

• ✓. Male or female ≥ 18 years. For Group 3 Cohorts 4 and 5 only male or female ≥18 years and pediatric patients 12-18 years and ≥40 kg body mass
• ✓. Written informed consent must be obtained prior to any screening procedures
• ✓. For AML, acute promyelocytic leukemia (APL) patients are not included in the study.
• ✓. Adequate hepatic function as evidenced by meeting all the following requirements:
• ✓. Measured or calculated (determined by the Cockcroft-Gault equation) serum creatinine clearance (CrCl) ≥ 60 mL/min (glomerular filtration rate can be alternative to CrCl) for adult patients or serum creatinine ≤ 1.5 x ULN; or if serum creatinine \> 1.5 x ULN, then serum creatinine clearance (CrCl) ≥ 50 mL/min (estimated by Cockcroft-Gault formula or other appropriate formula) for pediatric patients. Whether the value is calculated by equation or measured directly can be based on institutional standard practice.
• ✓. Amylase ≤ 1.5 × ULN.
• ✓. Eastern cooperative oncology group (ECOG) performance status 0-2.
• ✓. The electrolytes and uric acid level need to be stable judged by investigators for at least 3 days before the first dose of GFH009 (Medical intervention is permitted).

Exclusion criteria