[Translation] A single-arm, open-label, dose-escalation phase I clinical study evaluating the safety, tolerability, and preliminary efficacy of intravenous and intratumoral injection of OVV-01 in patients with advanced solid tumors.
主要目的:
评估OVV-01注射液静脉和瘤内给药在晚期实体瘤受试者中的安全性和耐受性,以确定最大耐受剂量(MTD)和II期推荐剂量(RP2D)。
次要目的:
评估OVV-01注射液静脉和瘤内给药在晚期实体瘤受试者中的初步疗效;
评估OVV-01注射液在晚期实体瘤受试者中的总体安全/耐受性;
评估OVV-01注射液在晚期实体瘤受试者中的生物分布和病毒脱落情况;
评估OVV-01注射液在晚期实体瘤受试者中的免疫原性;
探索OVV-01注射液在外周血和肿瘤组织中可预测疗效的潜在生物标志物和血液中的细胞因子释放情况(若根据实际情况可行)。
[Translation] Primary Objective: To evaluate the safety and tolerability of intravenous and intratumoral administration of OVV-01 injection in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose for Phase II (RP2D).
Secondary Objectives: To evaluate the preliminary efficacy of intravenous and intratumoral administration of OVV-01 injection in patients with advanced solid tumors; to evaluate the overall safety/tolerability of OVV-01 injection in patients with advanced solid tumors; to evaluate the biodistribution and viral shedding of OVV-01 injection in patients with advanced solid tumors; to evaluate the immunogenicity of OVV-01 injection in patients with advanced solid tumors; and to explore potential biomarkers for predicting efficacy of OVV-01 injection in peripheral blood and tumor tissue, and cytokine release in the blood (if feasible).