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

• 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.