Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome

Inclusion Criteria

• •Diagnosis of MDS by World Health Organization criteria, and either
• •1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:
• •i. Dose escalation portion: failed prior treatment with at least 4 cycles started of a hypomethylating agent (HMA; azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.
• •ii. Dose expansion portion: failed prior treatment defined as no response to treatment with at least 4 cycles started of HMA, loss of response at any time point, or progressive disease/intolerance to therapy ("HMA failure"); or no prior treatment with HMA ("HMA naive").
• •2. IPSS low risk or intermediate-1 risk patients with 5q deletion:
• •i. Dose escalation portion: failed prior treatment with at least 4 cycles started of lenalidomide and 4 cycles of hypomethylating agent (azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.
• •ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirement of failed prior treatment with lenalidomide defined as no response to treatment with at least 4 cycles started of lenalidomide, loss of response at any time point, or progressive disease/intolerance to therapy.
• •3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
• •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• •Screening laboratory values:
• •1. Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
• •2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
• •3. Bilirubin \< 1.5 times upper limit of normal;
• •4. No history of HIV being HIV positive;
• •5. No active Hepatitis B or Hepatitis C infection.
• •Life expectancy ≥ 12 weeks.
• •Women of childbearing potential (WOCBP) must use study specified contraception.
• •WOCBP demonstrate negative pregnancy test.
• •Not breastfeeding.
• •Men sexually active must use study specified contraception.