[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics and preliminary efficacy of LNF2008 in patients with advanced solid tumors
主要研究目的:
评估LNF2008在晚期实体瘤受试者中的安全性和耐受性;
评估LNF2008在晚期实体瘤受试者中的剂量限制性毒性(DLT),确定最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D)。
次要研究目的:
评估LNF2008在晚期实体瘤受试者中的药代动力学(PK)特征;
评估LNF2008在晚期实体瘤受试者中的初步疗效;
评估LNF2008在晚期实体瘤受试者中的免疫原性。
[Translation] Primary study objectives:
To evaluate the safety and tolerability of LNF2008 in subjects with advanced solid tumors;
To evaluate the dose-limiting toxicity (DLT) of LNF2008 in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended dose for Phase II (RP2D).
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics of LNF2008 in subjects with advanced solid tumors;
To evaluate the preliminary efficacy of LNF2008 in subjects with advanced solid tumors;
To evaluate the immunogenicity of LNF2008 in subjects with advanced solid tumors.