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一项评估SAK2001在晚期实体瘤受试者中的安全性、耐受性、药代动力学特征以及初步抗肿瘤疗效的Ι期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of SAK2001 in subjects with advanced solid tumors
主要目的:评价SAK2001在晚期实体瘤受试者中的安全性和耐受性,并观察该药的剂量限制性毒性(DLT),确定其在人体中的最大耐受剂量(MTD),为后续临床研究提供剂量选择依据;
次要目的:评价SAK2001在晚期实体瘤受试者中的药代动力学(PK)特征;初步评价SAK2001在晚期实体瘤受试者中的抗肿瘤疗效;
比较SAK2001与多西他赛注射液(泰索帝®)的PK特征、安全性和抗肿瘤疗效。
[Translation] Primary purpose: To evaluate the safety and tolerability of SAK2001 in subjects with advanced solid tumors, observe the dose-limiting toxicity (DLT) of the drug, determine its maximum tolerated dose (MTD) in humans, and provide a basis for dose selection for subsequent clinical studies;
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of SAK2001 in subjects with advanced solid tumors; To preliminarily evaluate the anti-tumor efficacy of SAK2001 in subjects with advanced solid tumors;
To compare the PK characteristics, safety and anti-tumor efficacy of SAK2001 with docetaxel injection (Taxotere®).
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