A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Inclusion Criteria:

* Written informed consent must be provided.
* Males and females age ≥ 18 years;
* Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following:

  1. Refractory to at least 1 cycle of induction chemotherapy, or
  2. Relapsed after at least 1 cycle of induction chemotherapy, or
  3. Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* In the absence of rapidly progressing disease, the interval from prior treatment to time of SKLB1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents;
* Serum creatinine ≤1.5 × ULN;
* Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement;
* Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement;
* Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study;

Exclusion Criteria:

* Histologic diagnosis of acute promyelocytic leukemia;
* Clinically active central nervous system leukemia;
* Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
* Bone marrow transplant within 100 days prior to study;
* Active, uncontrolled infection;
* Major surgery within 4 weeks prior to study;
* Radiation therapy within 4 weeks prior to study;
* Left ventricular ejection fraction ≤1 × ULN,or﹤50%. Clinically significant ECG QTc prolongation (Male: \>450ms, Female: \>470ms).Significant cardiac disease.
* Human immunodeficiency virus positivity;
* Active hepatitis B or C or other active liver disease;
* Women who are pregnant, lactating;
* Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.