[Translation] An open-label, dose-escalation, and expansion Phase I clinical study evaluating PT217 in subjects with advanced, refractory cancers expressing DLL3.
评估PT217在晚期实体瘤受试者中的安全性和耐受性,通过剂量递增评估PT217在晚期实体瘤中的限制毒性的发生情况,并确定最大耐受剂量(如达到),以及Ⅱ期推荐剂量。评估PT217在晚期实体瘤受试者中的药代动力学特征、免疫原性、细胞因子水平及初步的抗肿瘤活性。
[Translation] To evaluate the safety and tolerability of PT217 in subjects with advanced solid tumors, evaluate the occurrence of limiting toxicity of PT217 in advanced solid tumors through dose escalation, and determine the maximum tolerated dose (if reached) and the recommended dose for Phase II. To evaluate the pharmacokinetic characteristics, immunogenicity, cytokine levels and preliminary anti-tumor activity of PT217 in subjects with advanced solid tumors.