A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With 7+3 Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .
• Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.;
• Age ≥ 18 and \< 60 years;
• Subjects who are positive for FLT3 mutations by central laboratory;
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Subject must meet the following criteria as indicated on the clinical laboratory tests;
‣ Serum aspartate aminotransf
⁃ Total serum bilirubin ≤ 2.5 x institutional ULN
⁃ Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \> 30 ml/min
• Subject is suitable for oral administration of study drug.