[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of DN020198 tablets in subjects with advanced solid tumors
主要目的:评价 DN020198 片在标准治疗失败或标准治疗不耐受或目前无标准治疗的晚期实体瘤受试者中 的安全性和耐受性,确定其最大耐受剂量(MTD) 和/或 II 期推荐剂量(RP2D)。次要目的:评价 DN020198 片在标准治疗失败或标准治疗不耐受或目前无标准治疗的晚期实体瘤受试者中的药代动力学(PK)特征;评价 DN020198 片在标准治疗失败或标准治疗不耐受或目前无标准治疗的晚期实
体瘤受试者中的初步疗效(实体瘤缓解评价标准[RECIST] v1.1)。探索性目的:评价 DN020198 片激活免疫反应的程度,和初步疗效的相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of DN020198 tablets in subjects with advanced solid tumors who have failed or are intolerant to standard treatment or who currently have no standard treatment, and to determine its maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D). Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of DN020198 tablets in subjects with advanced solid tumors who have failed or are intolerant to standard treatment or who currently have no standard treatment; to evaluate the preliminary efficacy of DN020198 tablets in subjects with advanced solid tumors who have failed or are intolerant to standard treatment or who currently have no standard treatment (Response Evaluation Criteria in Solid Tumors [RECIST] v1.1). Exploratory objective: To evaluate the extent of immune response activated by DN020198 tablets and its correlation with preliminary efficacy.