[Translation] A non-randomized, open-label phase IIa clinical trial evaluating the safety, efficacy and pharmacokinetics of CT102 for injection in the treatment of primary liver cancer
主要目标:
1. 在Ⅰ期临床耐受性试验的基础上,进行多次给药的耐受性和安全性研究,获得多次给药的最大耐受剂量(MTD)、剂量限制性毒性(DLT)数据。
2. 进行单次给药和多次给药的药物代谢动力学研究,考察注射用CT102的药物代谢动力学特征,计算相应的药物代谢动力学参数。
次要目标:
进行多次给药的有效性研究,初步观察受试者相对基线肿瘤大小的变化,初步建立暴露-效应关系,为下一阶段临床试验推荐给药方案。
[Translation] main target:
1. On the basis of the Phase I clinical tolerability test, carry out multiple-dose tolerance and safety studies, and obtain the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) data of multiple doses .
2. Pharmacokinetic studies of single-dose and multiple-dose were carried out, the pharmacokinetic characteristics of CT102 for injection were investigated, and the corresponding pharmacokinetic parameters were calculated.
Secondary goals:
Carry out a multi-dose efficacy study, initially observe the changes in the subject's tumor size relative to the baseline, initially establish an exposure-effect relationship, and recommend a dosing regimen for the next phase of clinical trials.