[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BTK inhibitor TM471-1 capsules in patients with B-cell non-Hodgkin lymphoma (NHL)
剂量爬坡阶段:主要目的: (1)观察口服TM471-1胶囊单药在复发或难治B细胞NHL患者中的安全性和耐受性;(2)探索复发或难治B细胞NHL患者口服TM471-1胶囊单药的最大耐受剂量(maximal tolerated dose,MTD),II期推荐剂量(recommend phase 2 dose,RP2D)和剂量限制性毒性(dose-limiting toxicity,DLT)。次要目的:(1)评估TM471-1胶囊的药代动力学(pharmacokinetics,PK)特征;(2)评估TM471-1胶囊的药效学(pharmacodynamics,PD)特征; (3)初步观察TM471-1胶囊单药的抗肿瘤活性。
剂量扩展阶段:主要目的:评估TM471-1胶囊单药的有效性。次要目的:(1)评估TM471-1胶囊单药的安全性和耐受性;(2)探索TM471-1胶囊在脑脊液中的分布。
[Translation] Dose escalation phase: Primary objectives: (1) To observe the safety and tolerability of oral TM471-1 capsules alone in patients with relapsed or refractory B-cell NHL; (2) To explore the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) and dose-limiting toxicity (DLT) of oral TM471-1 capsules alone in patients with relapsed or refractory B-cell NHL. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of TM471-1 capsules; (2) To evaluate the pharmacodynamic (PD) characteristics of TM471-1 capsules; (3) To preliminarily observe the anti-tumor activity of TM471-1 capsules alone.
Dose expansion phase: Primary objectives: To evaluate the efficacy of TM471-1 capsules alone. Secondary objectives: (1) to evaluate the safety and tolerability of TM471-1 capsules alone; (2) to explore the distribution of TM471-1 capsules in cerebrospinal fluid.