In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The main study has completed enrollment. In Sub-studies 1 and 2, the effects of taking ziftomenib and other common drugs at the same time will be investigated in AML patients. In Sub-study 3, ziftomenib will be evaluated in patients with R/R acute lymphoblastic leukemia (ALL). In Sub-study 4, ziftomenib will be evaluated in patients with R/R AML with certain genetic mutations.
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Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
Timeframe: Dose Limiting Toxicities (DLTs) will be evaluated during the first 28 days (1 cycle)
Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first.
Phase 1b: Minimum biologically effective dose
Timeframe: For at least 12 months following end of treatment
Phase 1a, 1b, and 2: Evidence of anti-leukemia activity
Timeframe: For at least 12 months following end of treatment
Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam
Timeframe: Cycle 1 on Days 1 and 15 at predose and postdose
Sub-study 1: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and midazolam
Timeframe: Cycle 1 on Days 1 and 15 at predose and postdose
Sub-study 1: Maximum observed plasma concentration (Cmax) of ziftomenib and midazolam
Timeframe: Cycle 1 on Days 1 and 15 at predose and postdose
Sub-study 2: Time to observed maximum plasma concentration (Tmax) of ziftomenib and itraconazole
Timeframe: Cycle 1 on Days 1, 15, and 22 at predose and postdose
Sub-study 2: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and itraconazole
Timeframe: Cycle 1 on Days 1, 15, and 22 at predose and postdose
Sub-study 2: Maximum observed plasma concentration (Cmax) of ziftomenib and itraconazole
Timeframe: Cycle 1 on Days 1, 15, and 22 at predose and postdose
Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
Timeframe: During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first
Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
Timeframe: For at least 12 months following end of treatment
Sub-study 3: Change in Eastern Cooperative Oncology Group (ECOG) status
Timeframe: Timeframe: from Baseline to End of Treatment
Sub-study 3: Time to observed maximum plasma concentration (Tmax) of ziftomenib
Timeframe: Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards
Sub-study 3: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib
Timeframe: Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards
Sub-study 3: Maximum observed plasma concentration (Cmax) of ziftomenib
Timeframe: Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards.
Sub-study 4: Complete remission (CR) and complete remission with partial hematologic recovery (CRh)
Timeframe: For at least 12 months following end of treatment