KRT-232-104: This Phase I/II trial is trying determine the effectiveness of a targeted therapy drug (KRT-232) in combination with chemotherapy (cytarabine and decitabine) in people adults with acute myeloid leukaemiaAn Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

Exclusion

• Patients who are TP53 mutation positive
• Prior treatment with an MDM2 antagonist therapy
• Patients treated with ≥ 18 g/m2 of cytarabine within the prior 90 days are not eligible to be treated with cytarabine on this study but may be treated with decitabine (for Part A) .
• Patients previously treated with decitabine are not eligible to receive decitabine on this study but may be treated with cytarabine (for Part A) .
• Patients who have received an allogeneic HSCT within 90 days of enrollment or who have active graft-versus-host disease requiring active therapy (for Part A)
• Allogeneic stem cell transplant within 3 months; autologous stem cell transplant within 3 months or active graft-versus-host disease prior to first dose of study treatment (for Part B)
• Patients who have received immunosuppressive therapy for graft-versus-host disease within 1 month prior to enrollment into this study
• Patients who are eligible for an allogeneic HSCT per the opinion of the investigator and have a donor. Patients who are HSCT-eligible in the opinion of the investigator, but who refuse a transplant, are eligible for the study.
• Patients with known CNS involvement with AML, acute promyelocytic leukemia (APL), or a history of bleeding diathesis
• Patients who have had major surgery within 28 days prior to the first treatment with KRT-232
• Women who are pregnant or breastfeeding