[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of TR115 tablets in patients with relapsed/refractory non-Hodgkin's lymphoma or advanced solid tumors
主要研究目的:
评估TR115片单药口服给药在复发/难治性非霍奇金淋巴瘤或晚期实体瘤患者中的安全性和耐受性,确定剂量限制性毒性(DLT)和最大耐受剂量(MTD),推荐II期临床试验剂量(RP2D)。
次要研究目的:
评估TR115片单次和多次给药在复发/难治性非霍奇金淋巴瘤或晚期实体瘤患者的人体药代动力学(PK)特征。
探索性研究目的:
初步评估TR115片的抗肿瘤疗效(ORR、PFS、DOR、DCR和CBR,选择ORR和DOR为主要观察指标)和探索观察生物标志物H3K27Me3的变化。
[Translation] Main study objectives:
To evaluate the safety and tolerability of oral administration of TR115 tablets in patients with relapsed/refractory non-Hodgkin's lymphoma or advanced solid tumors, determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the Phase II clinical trial dose (RP2D).
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics of single and multiple administrations of TR115 tablets in patients with relapsed/refractory non-Hodgkin's lymphoma or advanced solid tumors.
Exploratory study objectives:
To preliminarily evaluate the anti-tumor efficacy of TR115 tablets (ORR, PFS, DOR, DCR and CBR, with ORR and DOR as the main observation indicators) and explore the changes in the biomarker H3K27Me3.