[Translation] To evaluate the safety, biodistribution and preliminary efficacy of intravenous administration of recombinant human PD-1 antibody herpes simplex virus (rHSV-1-APD1) for injection in patients with primary central nervous system tumors/solid tumors with brain metastases Phase I clinical study of climbing
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] Main objective: To evaluate the safety and tolerability of intravenous administration of rHSV-1-APD1 in patients with primary central nervous system tumors/solid tumor brain metastases, 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 profile of intravenously administered rHSV-1-APD1. To evaluate the preliminary antitumor efficacy of intravenous administration of rHSV-1-APD1 in patients with primary central nervous system tumors/solid tumors with brain metastases. To evaluate the relationship between the antitumor efficacy, pharmacodynamics and immunogenicity of rHSV-1-APD1 intravenous administration in patients with primary central nervous system tumor/solid tumor brain metastases. To evaluate the relationship between the safety and immunogenicity indicators of intravenous administration of rHSV-1-APD1.