[Translation] Phase Ia/Ib clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of KN052 in Chinese subjects with advanced solid tumors
主要研究目的:剂量递增期:评价 KN052 的 MTD 和/或 RP2D; 队列扩展期:评价 KN052 在特定瘤种中的抗肿瘤活性 次要研究目的:评价 KN052 的安全性和耐受性;评价 KN052 的药代动力学特征;评估 KN052 的免疫原性 探索性研究目的:探索生物标志物: 包括但不限于肿瘤组织中 PD-L1 表达、 TILs、基因突变或表达;外周血细胞因子水平、可溶性蛋白、免疫表型和 临床疗效的相关性;探索 PK 参数(如 Cmax,ss、 AUC tau,ss、 Ctrough,ss等)与临床疗效或免疫相关不良事件发生率之间的相关性。
[Translation] Primary study objectives: Dose escalation phase: to evaluate the MTD and/or RP2D of KN052; Cohort expansion phase: to evaluate the anti-tumor activity of KN052 in specific tumor types Secondary study objectives: to evaluate the safety and tolerability of KN052; to evaluate the pharmacokinetic characteristics of KN052; to evaluate the immunogenicity of KN052 Exploratory study objectives: to explore biomarkers: including but not limited to PD-L1 expression, TILs, gene mutations or expression in tumor tissues; the correlation between peripheral blood cytokine levels, soluble proteins, immune phenotypes and clinical efficacy; to explore the correlation between PK parameters (such as Cmax,ss, AUC tau,ss, Ctrough,ss, etc.) and clinical efficacy or the incidence of immune-related adverse events.