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.
在晚期高级别脑胶质瘤患者中评价注射用重组人 PD- 1 抗体单纯疱疹病毒（rHSV-1-APD1）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 recombinant human PD-1 antibody herpes simplex virus (rHSV-1-APD1) for injection in patients with advanced high-grade brain glioma
主要目的：评价晚期高级别脑胶质瘤患者术后 Ommaya 囊给药 rHSV-1-APD1 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：评价晚期高级别脑胶质瘤患者术后 Ommaya 囊给药 rHSV-1-APD1 的生物分布特征。评估晚期高级别脑胶质瘤患者术后 Ommaya 囊给药 rHSV-1-APD1 的初步抗肿瘤疗效。 评估晚期高级别脑胶质瘤患者术后 Ommaya 囊给药 rHSV-1-APD1 的抗肿瘤疗效
与药效学指标之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of rHSV-1-APD1 administered via Ommaya capsule after surgery in patients with advanced high-grade glioma, 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 rHSV-1-APD1 administered via Ommaya capsule after surgery in patients with advanced high-grade glioma. To evaluate the preliminary anti-tumor efficacy of rHSV-1-APD1 administered via Ommaya capsule after surgery in patients with advanced high-grade glioma. To evaluate the anti-tumor efficacy of rHSV-1-APD1 administered via Ommaya capsule after surgery in patients with advanced high-grade glioma
and the relationship between pharmacodynamic indicators.
100 Clinical Results associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.
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100 Translational Medicine associated with Zhejiang Yangshengtang Biotechnology Co., Ltd.
