[Translation] A multicenter, open-label Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of subcutaneous injection of DN1508052-01 combined with toripalimab in subjects with advanced solid tumors whose disease has progressed after standard treatment or who are intolerant to standard treatment or have no standard treatment
Part 1(联合特瑞普利单抗剂量探索):主要目的:评价DN1508052-01(简称DN052)皮下注射联合特瑞普利单抗(简称JS001)治疗晚期实体瘤受试者的安全性和耐受性,确定联合给药的最大耐受剂量(MTD)和/或推荐的II期临床试验联合用药剂量(RP2D)。次要目的:进一步评价联合治疗晚期实体瘤受试者的安全性和耐受性;评价联合给药在晚期实体瘤受试者中的有效性;评价联合给药PK特征;评价联合给药的PD特征;评价联合给药的生物标志物PD-L1/HPV/EBV感染情况与疗效的相关性。Part 2(联合特瑞普利单抗队列扩展):主要目的:评价联合给药在标准治疗后疾病进展或对标准治疗不耐受或无标准治疗的晚期实体瘤受试者中的初步疗效。次要目的:评价联合给药在标准治疗后疾病进展或对标准治疗不耐受或无标准治疗的晚期实体瘤受试者中的其他疗效指标;评价联合给药在标准治疗后疾病进展或对标准治疗不耐受或无标准治疗的晚期实体瘤受试者中的安全性和耐受性;评价联合给药的PK特征;评价联合给药的PD特征;评价联合给药的生物标志物PD-L1/HPV/EBV感染情况与疗效的相关性
[Translation] Part 1 (dose exploration in combination with toripalimab): Primary objective: To evaluate the safety and tolerability of subcutaneous injection of DN1508052-01 (DN052 for short) combined with toripalimab (JS001 for short) in the treatment of subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) of combined administration and/or the recommended combined dose (RP2D) of Phase II clinical trials. Secondary objectives: To further evaluate the safety and tolerability of combined treatment in subjects with advanced solid tumors; To evaluate the effectiveness of combined administration in subjects with advanced solid tumors; To evaluate the PK characteristics of combined administration; To evaluate the PD characteristics of combined administration; To evaluate the correlation between the biomarker PD-L1/HPV/EBV infection status of combined administration and the efficacy. Part 2 (cohort expansion in combination with toripalimab): Primary objective: To evaluate the preliminary efficacy of combined administration in subjects with advanced solid tumors whose disease has progressed after standard treatment or who are intolerant to standard treatment or have no standard treatment. Secondary objectives: To evaluate other efficacy indicators of the combination therapy in subjects with advanced solid tumors whose disease has progressed after standard treatment or who are intolerant to standard treatment or who have no standard treatment; To evaluate the safety and tolerability of the combination therapy in subjects with advanced solid tumors whose disease has progressed after standard treatment or who are intolerant to standard treatment or who have no standard treatment; To evaluate the PK characteristics of the combination therapy; To evaluate the PD characteristics of the combination therapy; To evaluate the correlation between the biomarker PD-L1/HPV/EBV infection status of the combination therapy and the efficacy