[Translation] A phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of CDK9 inhibitor YK-2168 in the treatment of patients with advanced solid tumors and lymphomas
评价 YK-2168 治疗晚期或不可切除的实体瘤以及复发性和/或难治性非霍奇金淋巴瘤患者的安全性和耐受性, 并探索 YK-2168 的最大耐受剂量(MTD),确定Ⅱ期临床试验推荐剂量(RP2D)。
评价 YK-2168 的药代动力学(PK)特征。
按照实体瘤疗效评价标准(RECIST 1.1)或淋巴瘤疗效评价标准(Lugano2014),通过客观缓解率(ORR)和疾病控制率(DCR)初步评价 YK-2168 的抗肿瘤疗效。
[Translation] To evaluate the safety and tolerability of YK-2168 in the treatment of patients with advanced or unresectable solid tumors and relapsed and/or refractory non-Hodgkin's lymphoma, and to explore the maximum tolerated dose (MTD) of YK-2168 and determine the recommended dose (RP2D) for Phase II clinical trials.
To evaluate the pharmacokinetic (PK) characteristics of YK-2168.
According to the solid tumor efficacy evaluation criteria (RECIST 1.1) or lymphoma efficacy evaluation criteria (Lugano 2014), the anti-tumor efficacy of YK-2168 was preliminarily evaluated by objective response rate (ORR) and disease control rate (DCR).