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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价CDK9抑制剂YK-2168治疗晚期实体瘤以及淋巴瘤患者的安全性、耐受性、药代动力学特征及初步疗效的I/IIa期临床试验
[Translation] Phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CDK9 inhibitor YK-2168 in 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 advanced or unresectable solid tumors and patients with relapsed and/or refractory non-Hodgkin lymphoma, and to explore the maximum tolerated dose (MTD) of YK-2168, Determine the recommended dose (RP2D) for phase II clinical trials.
To evaluate the pharmacokinetic (PK) profile of YK-2168.
According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) or the Response Evaluation Criteria for Lymphoma (Lugano2014), the antitumor efficacy of YK-2168 was preliminarily evaluated by objective response rate (ORR) and disease control rate (DCR).
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