[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of YKYY031 for injection in patients with advanced solid tumors.
主要目的:评估注射用YKYY031在晚期实体瘤患者中的安全性和耐受性,并观察注射用YKYY031的剂量限制性毒性、确定最大耐受剂量(如有)及推荐的II期临床剂量。
次要目的:评估注射用YKYY031在晚期实体瘤患者中的药代动力学特征。评估注射用YKYY031在晚期实体瘤患者中的初步抗肿瘤活性。评估注射用YKYY031在晚期实体瘤患者中的免疫原性。评估注射用YKYY031在晚期实体瘤患者中的免疫相关特征。
探索性目的:探索生物标志物与注射用YKYY031抗肿瘤活性的相关性。
[Translation] Primary Objective: To evaluate the safety and tolerability of YKYY031 for injection in patients with advanced solid tumors, and to observe dose-limiting toxicities, determine the maximum tolerated dose (if any), and the recommended phase II clinical dose.
Secondary Objectives: To evaluate the pharmacokinetic characteristics of YKYY031 for injection in patients with advanced solid tumors. To evaluate the preliminary antitumor activity of YKYY031 for injection in patients with advanced solid tumors. To evaluate the immunogenicity of YKYY031 for injection in patients with advanced solid tumors. To evaluate the immune-related characteristics of YKYY031 for injection in patients with advanced solid tumors.
Exploratory Objectives: To explore the correlation between biomarkers and the antitumor activity of YKYY031 for injection.