[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SKB410 for injection in subjects with advanced solid tumors
Ⅰa 期(剂量递增阶段) 主要目的: 评估 SKB410 在晚期实体瘤受试者中的安全性和耐受性。 次要目的: 评估 SKB410 在晚期实体瘤受试者中的药代动力学特征; 评估 SKB410 在晚期实体瘤受试者中的免疫原性; 评估 SKB410 在晚期实体瘤受试者中的初步疗效(疗效指标:ORR、DCR、 DOR、PFS、OS)。 Ⅰb 期(剂量扩展阶段) 主要目的: 初步评估选定剂量的 SKB410 在特定瘤种受试者中的客观缓解率(ORR)。 次要目的: 评估选定剂量的 SKB410 在特定瘤种受试者中的安全性和耐受性; 初步评估选定剂量的 SKB410 在特定瘤种受试者中的疗效(疗效指标:DCR、 DOR、PFS、OS); 评估 SKB410 在特定瘤种受试者中的药代动力学特征; 评估 SKB410 在特定瘤种受试者中的免疫原性。
[Translation] Phase Ia (dose escalation phase) Primary objective: To evaluate the safety and tolerability of SKB410 in subjects with advanced solid tumors. Secondary objectives: To evaluate the pharmacokinetic characteristics of SKB410 in subjects with advanced solid tumors; To evaluate the immunogenicity of SKB410 in subjects with advanced solid tumors; To evaluate the preliminary efficacy of SKB410 in subjects with advanced solid tumors (efficacy indicators: ORR, DCR, DOR, PFS, OS). Phase Ib (dose expansion phase) Primary objective: To preliminarily evaluate the objective response rate (ORR) of the selected dose of SKB410 in subjects with specific tumor types. Secondary objectives: To evaluate the safety and tolerability of the selected dose of SKB410 in subjects with specific tumor types; To preliminarily evaluate the efficacy of the selected dose of SKB410 in subjects with specific tumor types (efficacy indicators: DCR, DOR, PFS, OS); To evaluate the pharmacokinetic characteristics of SKB410 in subjects with specific tumor types; To evaluate the immunogenicity of SKB410 in subjects with specific tumor types.