[Translation] Phase I clinical study of the safety, tolerability, pharmacokinetics and anti-tumor activity of SKB500 for injection in subjects with advanced solid tumors
主要目的:
评估SKB500在晚期实体瘤受试者中的安全性和耐受性、剂量限制性毒性(DLT),确定最大耐受剂量(MTD)或最大给药剂量(MAD),以及Ⅱ期推荐剂量(RP2D)。
次要目的:
1) 评估SKB500在晚期实体瘤受试者中的药代动力学(PK)特征;
2) 评估SKB500在晚期实体瘤受试者中的免疫原性;
3) 初步评估SKB500在晚期实体瘤受试者中的抗肿瘤活性。
[Translation] Primary objectives:
Evaluate the safety and tolerability of SKB500 in subjects with advanced solid tumors, dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the recommended dose for Phase II (RP2D).
Secondary objectives:
1) Evaluate the pharmacokinetic (PK) characteristics of SKB500 in subjects with advanced solid tumors;
2) Evaluate the immunogenicity of SKB500 in subjects with advanced solid tumors;
3) Preliminary evaluation of the anti-tumor activity of SKB500 in subjects with advanced solid tumors.