[Translation] Phase I clinical study of the safety, tolerability, pharmacokinetics and anti-tumor activity of SKB518 for injection in subjects with advanced solid tumors
主要目的
1、评估SKB518单药治疗晚期实体瘤受试者的安全性和耐受性、剂量限制毒性(DLT),确定最大耐受剂量(MTD)和/或最大给药剂量(MAD)。
2、次要目的
评估SKB518在晚期实体瘤受试者中的药代动力学(PK)特征;
评估SKB518在晚期实体瘤受试者中的免疫原性;
基于实体瘤疗效评价标准(RECIST)v1.1,评估SKB518在晚期实体瘤受试者中的抗肿瘤活性。
[Translation] Main objectives
1. Evaluate the safety and tolerability of SKB518 monotherapy in subjects with advanced solid tumors, dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD).
2. Secondary objectives
Evaluate the pharmacokinetic (PK) characteristics of SKB518 in subjects with advanced solid tumors;
Evaluate the immunogenicity of SKB518 in subjects with advanced solid tumors;
Based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, evaluate the anti-tumor activity of SKB518 in subjects with advanced solid tumors.