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非在研适应症- |
最高研发阶段临床1期 |
首次获批国家/地区- |
首次获批日期1800-01-20 |
评估TSN084片治疗晚期恶性肿瘤受试者的安全性、耐受性、药代动力学、药效动力学特征及初步疗效的开放、多中心、Ia/Ib期研究
主要研究目的:评估TSN084片在晚期或转移性恶性肿瘤受试者中的安全性、耐受性、剂量限制性毒性(DLTs)和初步抗肿瘤活性,确定最大耐受剂量(MTD)、扩展期推荐剂量(RDE)和II期临床研究推荐剂量。次要研究目的:评估TSN084片药代动力学(PK)特征和初步抗肿瘤活性。探索性研究目的:探索TSN084的暴露量/剂量与安全性以及临床疗效之间的关系以及生物标志物。
A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors.
TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China.
A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors.
TSN084 is a novel type II protein kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies.
100 项与 CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8 相关的临床结果
100 项与 CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8 相关的转化医学
0 项与 CDK19 x FLT3 x c-Met x NTRK x AXL x CDK8 相关的专利(医药)