[Translation] Dose escalation, dose exploratory and dose expansion trials of CX1440 capsules to evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory B-lymphocytic malignancies.
主要目的
观察口服不同剂量的CX1440胶囊在复发/难治B淋巴细胞恶性肿瘤患者中的安全性和耐受性,确定可能出现的最大耐受剂量(MTD)和剂量限制性毒性(DLT)。
次要目的
考察单次和多次连续给药口服CX1440胶囊在人体内的药代动力学(PK)参数。
测量药效学(PD)参数,包括BTK靶酶的药物占有率。
初步评估CX1440胶囊的临床抗肿瘤疗效。
[Translation] Primary objective
To observe the safety and tolerability of oral CX1440 capsules at different doses in patients with relapsed/refractory B-lymphocyte malignancies and determine the possible maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
Secondary objective
To investigate the pharmacokinetic (PK) parameters of single and multiple continuous oral administration of CX1440 capsules in humans.
To measure pharmacodynamic (PD) parameters, including drug occupancy of BTK target enzyme.
To preliminarily evaluate the clinical anti-tumor efficacy of CX1440 capsules.