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一项评价BTK蛋白降解剂HZ-Q1070治疗复发或难治性B细胞恶性肿瘤的安全性/耐受性和药代动力学/药效动力学的I期临床研究
[Translation] A Phase I clinical study evaluating the safety/tolerability and pharmacokinetics/pharmacodynamics of the BTK protein degrader HZ-Q1070 in the treatment of relapsed or refractory B-cell malignancies
主要目的:1)评估HZ-Q1070在复发或难治性B细胞恶性肿瘤患者中的安全性/耐受性;2)确定HZ-Q1070最大耐受剂量(MTD)及II期临床推荐剂量(RP2D)。次要目的:1)评估HZ-Q1070在复发或难治性B细胞恶性肿瘤患者中的药代动力学(PK)特征和药效动力学(PD)特征;2)初步评价HZ-Q1070在复发或难治性B细胞恶性肿瘤患者的有效性。
[Translation] Primary objectives: 1) Evaluate the safety/tolerability of HZ-Q1070 in patients with relapsed or refractory B-cell malignancies; 2) Determine the maximum tolerated dose (MTD) and recommended dose (RP2D) for Phase II clinical trials of HZ-Q1070. Secondary objectives: 1) Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HZ-Q1070 in patients with relapsed or refractory B-cell malignancies; 2) Preliminary evaluation of the effectiveness of HZ-Q1070 in patients with relapsed or refractory B-cell malignancies.
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100 Translational Medicine associated with Zhongke Bohai Rim (Yantai) Advanced Institute of Pharmaceutical Sciences Co., Ltd.