评价注射用重组人PD-1抗体单纯疱疹病毒(rHSV-1-APD1)治疗晚期肝细胞癌的安全性、生物分布和初步疗效的单臂、剂量爬坡Ⅰ期临床研究
[Translation] A single-arm, dose-escalating phase I clinical study to evaluate the safety, biodistribution and preliminary efficacy of recombinant human PD-1 antibody herpes simplex virus for injection (rHSV-1-APD1) in the treatment of advanced hepatocellular carcinoma
主要目的:评价rHSV-1-APD1治疗晚期肝细胞癌患者的安全性和耐受性,确定最大耐受剂量(MTD)/推荐的II期临床剂量(RP2D)和剂量限制性毒性(DLT)。 次要目的:评价rHSV-1-APD1治疗晚期肝细胞癌患者的生物分布特征。评价rHSV-1-APD1治疗晚期肝细胞癌患者的初步抗肿瘤疗效。 探究rHSV-1-APD1治疗晚期肝细胞癌患者的药效学和免疫原性。
[Translation] Primary objectives: To evaluate the safety and tolerability of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma, determine the maximum tolerated dose (MTD)/recommended phase II clinical dose (RP2D) and dose-limiting toxicity (DLT). Secondary objectives: To evaluate the biodistribution characteristics of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma. To evaluate the preliminary anti-tumor efficacy of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma. To explore the pharmacodynamics and immunogenicity of rHSV-1-APD1 in the treatment of patients with advanced hepatocellular carcinoma.
评价注射用重组人 PD-1 抗体单纯疱疹病毒(rHSV-1-APD1)静脉给药治疗原发性中枢神经系统肿瘤/实体瘤脑转移患者的安全性、生物分布和初步疗效的单臂、剂量爬坡的Ⅰ期临床研究
[Translation] A single-arm, dose-escalating phase I clinical study to evaluate the safety, biodistribution and preliminary efficacy of intravenous administration of recombinant human PD-1 antibody herpes simplex virus for injection (rHSV-1-APD1) in patients with primary central nervous system tumors/brain metastases from solid tumors
主要目的:评价 rHSV-1-APD1 静脉给药治疗原发性中枢神经系统肿瘤/实体瘤脑转移患者的安全性和耐受性,确定最大耐受剂量(MTD)/推荐的 II 期临床剂量(RP2D)和剂量限制性毒性(DLT)。 次要目的:评价 rHSV-1-APD1 静脉给药的生物分布特征。评价 rHSV-1-APD1 静脉给药对原发性中枢神经系统肿瘤/实体瘤脑转移患者的初步抗肿瘤疗效。评价 rHSV-1-APD1 静脉给药治疗原发性中枢神经系统肿瘤/实体瘤脑转移患者的抗肿瘤疗效与药效学指标、免疫原性指标之间的关系。评价 rHSV-1-APD1 静脉给药的安全性与免疫原性指标之间的关系。
[Translation] Primary objectives: To evaluate the safety and tolerability of intravenous administration of rHSV-1-APD1 in the treatment of patients with primary central nervous system tumors/brain metastases from solid tumors, and to determine the maximum tolerated dose (MTD)/recommended phase II clinical dose (RP2D) and dose-limiting toxicity (DLT). Secondary objectives: To evaluate the biodistribution characteristics of intravenous administration of rHSV-1-APD1. To evaluate the preliminary anti-tumor efficacy of intravenous administration of rHSV-1-APD1 in patients with primary central nervous system tumors/brain metastases from solid tumors. To evaluate the relationship between the anti-tumor efficacy of intravenous administration of rHSV-1-APD1 in the treatment of patients with primary central nervous system tumors/brain metastases from solid tumors and pharmacodynamic indicators and immunogenicity indicators. To evaluate the relationship between the safety of intravenous administration of rHSV-1-APD1 and immunogenicity indicators.
评价注射用重组人 PD-1 抗体单纯疱疹病毒(rHSV-1-APD1) 静脉给药治疗晚期实体瘤患者的安全性、生物分布和初步疗效的单臂、剂量爬坡Ⅰ期临床研究
[Translation] A single-arm, dose-escalating phase I clinical study to evaluate the safety, biodistribution and preliminary efficacy of intravenous administration of recombinant human PD-1 antibody herpes simplex virus for injection (rHSV-1-APD1) in patients with advanced solid tumors
主要目的:评价 rHSV-1-APD1 静脉给药治疗晚期实体瘤患者的安全性和耐受性,确定最大耐受剂量(MTD) /推荐的 II 期临床剂量(RP2D)和剂量限制性毒性(DLT)。
次要目的:评价 rHSV-1-APD1 静脉给药的生物分布特征。评估 rHSV-1-APD1 静脉给药治疗晚期实体瘤患者的初步抗肿瘤疗效。评估 rHSV-1-APD1 静脉给药治疗晚期实体瘤患者的抗肿瘤疗效与药效学指标、免疫原性指标之间的关系。评估 rHSV-1-APD1 静脉给药治疗晚期实体瘤患者的安全性与免疫原性指标之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of intravenous administration of rHSV-1-APD1 in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD)/recommended phase II clinical dose (RP2D) and dose-limiting toxicity (DLT).
Secondary objective: To evaluate the biodistribution characteristics of intravenous administration of rHSV-1-APD1. To evaluate the preliminary anti-tumor efficacy of intravenous administration of rHSV-1-APD1 in patients with advanced solid tumors. To evaluate the relationship between the anti-tumor efficacy of intravenous administration of rHSV-1-APD1 in patients with advanced solid tumors and pharmacodynamic and immunogenicity indicators. To evaluate the relationship between the safety and immunogenicity indicators of intravenous administration of rHSV-1-APD1 in patients with advanced solid tumors.
100 Clinical Results associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.
100 Deals associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.
100 Translational Medicine associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.