[Translation] A multicenter, open-label, exploratory phase II clinical study to evaluate the safety, tolerability and preliminary efficacy of TJ107 combined with pembrolizumab injection in patients with locally advanced or metastatic solid tumors
主要目的:1.评价TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者中的安全性和耐受性; 2.探索TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者中的初步疗效。 次要目的:1.考察TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者的药效动力学特征;2.考察TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者中的药代动力学特征;3.考察TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者中的免疫原性。 其他目的:1.探索TJ107联用帕博利珠单抗注射液在局部晚期或转移性实体瘤患者中疗效相关的生物标记物。
[Translation] Main purposes: 1. To evaluate the safety and tolerability of TJ107 combined with pembrolizumab injection in patients with locally advanced or metastatic solid tumors; 2. To explore the efficacy of TJ107 combined with pembrolizumab injection in patients with locally advanced or preliminary efficacy in patients with metastatic solid tumors. Secondary objectives: 1. To investigate the pharmacodynamics of TJ107 combined with pembrolizumab injection in patients with locally advanced or metastatic solid tumors; 2. To investigate the efficacy of TJ107 combined with pembrolizumab injection in locally advanced or metastatic solid tumors. Pharmacokinetic characteristics in patients with metastatic solid tumors; 3. To investigate the immunogenicity of TJ107 combined with pembrolizumab injection in patients with locally advanced or metastatic solid tumors. Other purposes: 1. To explore the biomarkers related to the efficacy of TJ107 combined with pembrolizumab injection in patients with locally advanced or metastatic solid tumors.