A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
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Maximum Tolerated Dose (MTD)
Timeframe: up to 13 cycles (one cycle has 4 weeks)
Recommended Phase 2 dose (RP2D)
Timeframe: up to 13 cycles (one cycle has 4 weeks)
The pharmacokinetic (PK) profile of LP-108: Maximum Plasma Concentration [Cmax]
Timeframe: At Cycle 1 Day 1 (24 h PK), Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1 (24 h PK)
The PK profile of LP-108: Area Under the Curve [AUC]
Timeframe: At Cycle 1 Day 1 (24 h PK), Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1 (24 h PK)
The PK profile of LP-108: Time at Maximum Concentration [Tmax]
Timeframe: At Cycle 1 Day 1 (24 h PK), Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 2 Day 1 (24 h PK)