• Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active for refractory/relapsed AML

• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2

• For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy

• Participants must have adequate hepatic and renal functions as defined by:

‣ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and

⁃ Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And;

⁃ Estimated creatinine clearance of at least 60 mL/min. These estimations are calculated using the Cockcroft-Gault equation.

• Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine

• Male participants must agree to use an acceptable method of contraception for the duration of the study

• Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment

• Participants must be willing and able to provide written informed consent