[Translation] A single-arm, open-label, multicenter phase I clinical trial to evaluate the safety, pharmacokinetic properties and preliminary efficacy of HEC89736PTSA·0.5H2O in subjects with relapsed/refractory B-cell hematological malignancies
主要目的
评估复发/难治B细胞血液肿瘤受试者连续服用不同剂量HEC89736PTSA·0.5H2O的耐受性和安全性,观察剂量限制性毒性(Dose Limited Toxicity,DLT),确定MTD,确定II期推荐剂量(Recommended Phase II Dose,RP2D),为后续临床试验给药剂量和给药方案提供依据。
次要目的
观察HEC89736PTSA·0.5H2O在人体中的药代动力学(pharmacokinetics,PK)特征;
初步评估HEC89736PTSA·0.5H2O在各种B细胞血液肿瘤中的疗效。
探索目的
初步探索服用HEC89736PTSA·0.5H2O前后药效学(pharmacodynamics,PD)/生物标记物指标的变化以及与PK/疗效/剂量的相关性。
[Translation] Main purpose
Evaluate the tolerability and safety of HEC89736PTSA·0.5H2O in subjects with relapsed/refractory B-cell hematological tumors after continuous administration of different doses, observe dose-limiting toxicity (DLT), determine MTD, determine the recommended Phase II dose (RP2D), and provide a basis for the subsequent clinical trial dosage and administration schedule.
Secondary purpose
Observe the pharmacokinetic (PK) characteristics of HEC89736PTSA·0.5H2O in humans;
Preliminary evaluation of the efficacy of HEC89736PTSA·0.5H2O in various B-cell hematological tumors.
Exploration purpose
Preliminary exploration of the changes in pharmacodynamics (PD)/biomarker indicators before and after taking HEC89736PTSA·0.5H2O and their correlation with PK/efficacy/dose.