[Translation] Phase I/II clinical study of the safety, tolerability, and efficacy of N-3C01 monotherapy and its combination with PD-(L)1 monoclonal antibody in patients with advanced malignant solid tumors.
I 期主要研究目的
评价N-3C01 单药及联合PD-(L)1 单抗皮下注射治疗晚期实体瘤患者的可耐受性和安全性,确定最大耐受剂量(MTD)和II 期推荐剂量(RP2D)。
I 期次要研究目的
评价N-3C01 单药及联合PD-(L)1 单抗皮下注射治疗晚期实体瘤患者的药代动力学及免疫原性特征。评价N-3C01 单药及联合PD-(L)1 单抗皮下注射治疗晚期实体瘤患者的初步有效性。
I 期探索性研究目的
评价N-3C01 单药及联合PD-(L)1 单抗皮下注射治疗晚期实体瘤患者的生物标志物的变化。
II 期主要研究目的
评价N-3C01 在RP2D 下联合PD-(L)1 单抗皮下注射治疗选择的晚期实体瘤患者的有效性。
II 期次要研究目的
评价N-3C01 联合PD-(L)1 单抗皮下注射治疗选择的晚期实体瘤患者安全性。评价N-3C01 联合PD-(L)1 单抗皮下注射治疗选择的晚期实体瘤患者的药代动力学和免疫原性特征。
II 期探索性研究目的
评价N-3C01 联合PD-(L)1 单抗皮下注射治疗选择的晚期实体瘤患者的生物标志物的变化。
[Translation] Phase I Primary Study Objective:
Evaluate the tolerability and safety of N-3C01 monotherapy and its combination with PD-(L)1 monoclonal antibody subcutaneously in patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) and the recommended dose for Phase II (RP2D).
Phase I Secondary Study Objectives:
Evaluate the pharmacokinetics and immunogenicity of N-3C01 monotherapy and its combination with PD-(L)1 monoclonal antibody subcutaneously in patients with advanced solid tumors.
Phase I Exploratory Study Objective:
Evaluate changes in biomarkers in patients with advanced solid tumors treated with N-3C01 monotherapy and its combination with PD-(L)1 monoclonal antibody subcutaneously.
Phase II Primary Study Objective:
Evaluate the efficacy of N-3C01 combined with PD-(L)1 monoclonal antibody subcutaneously at RP2D in selected patients with advanced solid tumors.
Phase II Secondary Study Objectives:
Evaluate the safety of N-3C01 combined with subcutaneous PD-(L)1 monoclonal antibody in selected patients with advanced solid tumors.
Evaluate the pharmacokinetic and immunogenic characteristics of N-3C01 combined with subcutaneous PD-(L)1 monoclonal antibody in selected patients with advanced solid tumors.
Phase II Exploratory Study Objectives:
Evaluate changes in biomarkers in N-3C01 combined with subcutaneous PD-(L)1 monoclonal antibody in selected patients with advanced solid tumors.