[Translation] A multicenter, open-label, double-cohort phase II clinical study: Evaluating the safety and preliminary efficacy of FH-2001 capsules combined with slulizumab injection in the treatment of patients with advanced solid tumors
安全性导入阶段主要目的:评价FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的安全性和耐受性。次要目的: 描述FH-2001胶囊联合斯鲁利单抗单次、多次口服给药后的药代动力学特征;评价FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的初步疗效。II期剂量扩展阶段主要目的:确定 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌的RP3D; 评价 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的初步疗效。次要目的:评价 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的安全性。
[Translation] The main purpose of the safety lead-in phase is to evaluate the safety and tolerability of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. Secondary objectives: To describe the pharmacokinetic characteristics of FH-2001 capsule combined with slulizumab after single and multiple oral administration; to evaluate the preliminary efficacy of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. The main purpose of the Phase II dose expansion phase is to determine the RP3D of FH-2001 capsule combined with slulizumab injection in advanced hepatocellular carcinoma; to evaluate the preliminary efficacy of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. Secondary objectives: To evaluate the safety of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer.