[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of intratumoral injection of nano-carbon iron suspension injection (CNSI-Fe) in patients with advanced solid tumors
主要目的:评估瘤内注射不同剂量的纳米炭铁混悬注射液(CNSI-Fe)在晚期实体瘤患者中的安全性和耐受性,并观察CNSI-Fe的剂量限制性毒性(DLT),确定在人体的最大耐受剂量(MTD)或最高注射剂量,为后续临床研究提供剂量选择依据。次要目的:评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的药代动力学(PK)特征;初步评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的疗效。探索性目的:评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内药效动力学(PD)特征(不作强制要求);评估瘤内注射不同剂量的CNSI-Fe在晚期实体瘤患者中的瘤内PK特征(不作强制要求);探索瘤内注射CNSI-Fe的瘤体大小与CNSI-Fe注射剂量、给药浓度间的量效关系(不作强制要求)。
[Translation] Main purpose: To evaluate the safety and tolerability of intratumoral injection of different doses of nano-carbon iron suspension injection (CNSI-Fe) in patients with advanced solid tumors, and to observe the dose-limiting toxicity (DLT) of CNSI-Fe, Determine the maximum tolerated dose (MTD) or the highest injected dose in humans to provide the basis for dose selection for subsequent clinical studies. Secondary objectives: To evaluate the pharmacokinetics (PK) characteristics of intratumoral injection of different doses of CNSI-Fe in patients with advanced solid tumors; to preliminarily evaluate the efficacy of intratumoral injection of different doses of CNSI-Fe in patients with advanced solid tumors. Exploratory purpose: To evaluate the intratumoral pharmacodynamic (PD) characteristics of different doses of CNSI-Fe injected by intratumoral injection in patients with advanced solid tumors (not mandatory); Intratumoral PK characteristics in tumor patients (not mandatory); explore the dose-response relationship between the tumor size of intratumoral injection of CNSI-Fe and the dose and concentration of CNSI-Fe injection (not mandatory).