[Translation] Safety, tolerability, PK/PD and preliminary efficacy of KLT-1101 combined with toripalimab injection in the treatment of patients with melanoma and other solid tumors, open-label phase Ib/II clinical trial
主要目的:
评价KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中的安全性、耐受性;
次要目的:
评价KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中的初步疗效;
评价KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中的药代动力学(PK)特征;
评价KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中的免疫原性;
探索性目的:
探索KLT-1101与特瑞普利单抗注射液联合药物暴露水平与安全性的相关性;
探索KLT-1101 与特瑞普利单抗注射液联合PK/PD,以发现暴露浓度与效应细胞因子的相关性;
评价KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中抗肿瘤疗效相关的生物标志物随时间的变化;
评价KLT-1101与特瑞普利单抗注射液联合的药物暴露水平与抗肿瘤疗效的相关性;
确定KLT-1101与特瑞普利单抗注射液联合在黑色素瘤及其他实体瘤患者中的Ⅱ期推荐剂量(RP2D) ;
[Translation] Main purpose:
To evaluate the safety and tolerability of KLT-1101 combined with Teplizumab injection in patients with melanoma and other solid tumors;
Secondary purpose:
To evaluate the preliminary efficacy of KLT-1101 combined with Teplizumab injection in patients with melanoma and other solid tumors;
To evaluate the pharmacokinetic (PK) characteristics of KLT-1101 combined with Teplizumab injection in patients with melanoma and other solid tumors;
To evaluate the immunogenicity of KLT-1101 combined with Teplizumab injection in patients with melanoma and other solid tumors;
Exploratory purpose:
To explore the correlation between drug exposure level and safety of KLT-1101 combined with Teplizumab injection;
To explore the relationship between KLT-1101 and Teplizumab injection in patients with melanoma and other solid tumors; Combined PK/PD with Teplizumab injection to find the correlation between exposure concentration and effector cytokines;
Evaluate the changes in biomarkers related to the anti-tumor efficacy of KLT-1101 combined with Teplizumab injection over time in patients with melanoma and other solid tumors;
Evaluate the correlation between drug exposure level and anti-tumor efficacy of KLT-1101 combined with Teplizumab injection;
Determine the phase II recommended dose (RP2D) of KLT-1101 combined with Teplizumab injection in patients with melanoma and other solid tumors;