[Translation] A multi-center, open phase Ib/II clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of JC-5411-L in patients with advanced solid tumors
主要研究目的:
Ⅰb期:评价JC-5411-L在晚期实体瘤患者的安全性和耐受性,探索JC-5411-L的最大
耐受剂量(MTD),确定II期临床研究推荐剂量(RP2D)。
Ⅱ期:评价JC-5411-L在卵巢癌患者中的有效性和安全性。
次要研究目的:
评价JC-5411-L的药代动力学(PK)特征。
初步评价JC-5411-L治疗晚期实体瘤患者的疗效。
探索性研究目的
评价晚期实体瘤患者的肿瘤标本或外周血中的生物标记物水平(包括但不限于p53
蛋白表达水平)与疗效的关系。
评价晚期实体瘤患者的GST基因型与疗效的关系。
[Translation] Main research purposes:
Phase Ib: To evaluate the safety and tolerability of JC-5411-L in patients with advanced solid tumors, and to explore the maximum potential of JC-5411-L
Tolerated dose (MTD), to determine the recommended dose (RP2D) of phase II clinical studies.
Phase II: To evaluate the efficacy and safety of JC-5411-L in patients with ovarian cancer.
Secondary research purposes:
To evaluate the pharmacokinetic (PK) characteristics of JC-5411-L.
Preliminary evaluation of the efficacy of JC-5411-L in the treatment of patients with advanced solid tumors.
purpose of exploratory research
Evaluate biomarker levels (including but not limited to p53) in tumor specimens or peripheral blood of patients with advanced solid tumors
Protein expression level) and the relationship between curative effect.
To evaluate the relationship between GST genotype and efficacy in patients with advanced solid tumors.