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Clinical Trials associated with KL-A289KL-A289注射液在晚期实体瘤患者中单药治疗或联合治疗的Ⅰa/Ⅰb期临床试验
[Translation] Phase Ia/Ib clinical trial of KL-A289 injection as monotherapy or combination therapy in patients with advanced solid tumors
Ⅰa期主要目的:1)评估KL-A289注射液在晚期实体瘤患者中单药治疗的安全性和耐受性;2)确定Ⅰb/Ⅱ期研究中KL-A289注射液的推荐剂量。Ⅰa期次要目的:1)评估KL-A289注射液在晚期实体瘤患者中的药代动力学特征;2)评估KL-A289注射液在晚期实体瘤患者中的免疫原性;3)观察KL-A289注射液在晚期实体瘤患者中的初步疗效。
Ⅰb期主要目的:1)评估KL-A289注射液联合白蛋白紫杉醇在晚期实体瘤患者中的安全性和耐受性;2)确定联合治疗中KL-A289的最佳剂量。Ⅰb期次要目的:1)评估KL-A289注射液联合白蛋白紫杉醇在晚期实体瘤患者中的药代动力学特征;2)评估KL-A289注射液联合白蛋白紫杉醇在晚期实体瘤患者中的免疫原性;3)评估KL-A289注射液联合白蛋白紫杉醇在晚期实体瘤患者中的初步疗效。
[Translation] The main objectives of Phase Ia: 1) To evaluate the safety and tolerability of KL-A289 injection as a monotherapy in patients with advanced solid tumors; 2) To determine the recommended dose of KL-A289 injection in Phase Ib/II studies. Secondary objectives of Phase Ia: 1) To evaluate the pharmacokinetic characteristics of KL-A289 injection in patients with advanced solid tumors; 2) To evaluate the immunogenicity of KL-A289 injection in patients with advanced solid tumors; 3) To observe the preliminary efficacy of KL-A289 injection in patients with advanced solid tumors.
The main objectives of Phase Ib: 1) To evaluate the safety and tolerability of KL-A289 injection combined with albumin paclitaxel in patients with advanced solid tumors; 2) To determine the optimal dose of KL-A289 in combination therapy. The secondary objectives of Phase Ib are: 1) to evaluate the pharmacokinetic characteristics of KL-A289 injection combined with albumin-paclitaxel in patients with advanced solid tumors; 2) to evaluate the immunogenicity of KL-A289 injection combined with albumin-paclitaxel in patients with advanced solid tumors; 3) to evaluate the preliminary efficacy of KL-A289 injection combined with albumin-paclitaxel in patients with advanced solid tumors.
100 Clinical Results associated with KL-A289
100 Translational Medicine associated with KL-A289
100 Patents (Medical) associated with KL-A289
100 Deals associated with KL-A289