[Translation] A Phase I clinical study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of LH-1802 capsules in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
主要目的:评价 LH-1802 胶囊在复发/难治性急性髓系白血病(R/R AML)或骨髓增生异常综合征(R/R MDS)患者中的安全性和耐受性,确定最大耐受剂量和剂量限制毒性;探索 LH-1802 胶囊的 II 期推荐给药剂量(RP2D)和给药方案。 次要目的:评价 LH-1802 胶囊在 R/R AML 或 R/R MDS 患者中的药代动力学(PK) 特征;评价 LH-1802 胶囊在 R/R AML 或 R/R MDS 患者中的药效动力学(PD) 特征;评估 LH-1802 胶囊单药治疗 R/R AML 或 R/R MDS 患者的初步疗效。
[Translation] Primary objectives: To evaluate the safety and tolerability of LH-1802 capsules in patients with relapsed/refractory acute myeloid leukemia (R/R AML) or myelodysplastic syndrome (R/R MDS), determine the maximum tolerated dose and dose-limiting toxicity; explore the Phase II recommended dose (RP2D) and dosing regimen of LH-1802 capsules. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of LH-1802 capsules in patients with R/R AML or R/R MDS; to evaluate the pharmacodynamic (PD) characteristics of LH-1802 capsules in patients with R/R AML or R/R MDS; to evaluate the preliminary efficacy of LH-1802 capsules as a single agent in the treatment of patients with R/R AML or R/R MDS.