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)

Summary

This is a non-randomised trial with three experimental arms. In Experimental Arm 1, participants will receive KRT-232+LDAC. KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with LDAC administered at 20 mg/m2/day subcutaneously on Days 1-10 in a 28-day cycle. In Experimental Arm 2, participants will receive KRT-232 (7-Day) + Decitabine. KRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle. In Experimental Arm 3, participants will receive KRT-232 (14-Day) + Decitabine. KRT-232 will be administered orally, once daily (QD), on Days 1-7 and Days 15-21 (7 days on/7 days off/7 days on/7 days off) in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.