[Translation] An open-label, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia
主要目的:评价PBSS1113治疗复发/难治性急性髓系白血病患者中的安全性、耐受性,确定最大耐受剂量(MTD)以及II期推荐给药剂量(RP2D)。
次要目的:
1)评价PBSS1113在复发/难治性急性髓系白血病患者中的药代动力学(PK)特征;
2)评价食物对PBSS1113在复发/难治性髓系白血病患者中的PK的影响;
3)观察PBSS1113在复发/难治性急性髓系白血病患者中的初步疗效。
探索性目的:
1)评价PBSS1113在复发/难治性急性髓系白血病患者中的药效动力学(PD)特征;
2)探索PBSS1113的主要代谢产物在复发/难治性急性髓系白血病患者中的药代动力学(PK)特征。
[Translation] Primary objective: To evaluate the safety and tolerability of PBSS1113 in the treatment of patients with relapsed/refractory acute myeloid leukemia, and to determine the maximum tolerated dose (MTD) and the recommended dose (RP2D) for Phase II.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia;
2) To evaluate the effect of food on the PK of PBSS1113 in patients with relapsed/refractory myeloid leukemia;
3) To observe the preliminary efficacy of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia.
Exploratory objectives:
1) To evaluate the pharmacodynamic (PD) characteristics of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia;
2) To explore the pharmacokinetic (PK) characteristics of the main metabolites of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia.