Hua Yingqi, Wang Chongren, Li Fan, Han Yanjie, Zuo Dongqing, Lv Yu, Sun Mengxiong, Yuan Peng, Yuan Ruirong, Zhang Fan, Ma Liang, Wang Yan, Wu Hui, Zhou Guoqing, Lin Qiang, Wang Shuhang, Li Ning, Lu Yinying
Department of Orthopedic Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
GoBroad Medical (Hematology), Beijing Research Center / Beijing GoBroad Boren Hospital, Beijing, China.
J Immunother Cancer. 2025 Jun 5;13(6):e011517. doi: 10.1136/jitc-2025-011517.
OVV-01 is a genetically engineered vesicular stomatitis virus oncolytic virus designed to selectively amplify in tumor cells and express tumor-associated antigen NY-ESO-1. This study was designed to evaluate the safety, tolerability, and efficacy of OVV-01 in patients with advanced solid tumors.
This is a phase 1, first-in-human, open-label, multicenter study of OVV-01 in patients with advanced solid tumors. OVV-01 was intratumorally injected biweekly (every two weeks, Q2W), 3 weeks after the first dose for a total of six doses. Dose escalation follows a 3+3 design at four doses of 6×10 Plaue-Forming Unit (PFU), 6×10 PFU, 6×10 PFU, and 1.2×10 PFU. The primary endpoints were safety and tolerability. The second endpoints included overall response rate (ORR) and disease control rate (DCR) of OVV-01, by investigators per Response Evaluation Criteria in Solid Tumors V.1.1.
18 patients were enrolled into four dose groups, among whom 6 were soft tissue sarcoma (STS). No dose-limiting toxicities and treatment-related severe adverse events were observed. 11 patients were evaluated for efficacy, and the ORR was 27.3%, and the DCR was 63.6%. Among the four evaluable patients with advanced STS, the ORR was 75%. Two patients with STS achieved CR at doses above 6.0×10 PFU.
The intratumor injection of OVV-01 was safe and well-tolerated in patients with advanced solid tumors. A significant response was observed in patients with STS.
NCT04787003.
OVV-01是一种基因工程改造的水泡性口炎病毒溶瘤病毒，旨在选择性地在肿瘤细胞中扩增并表达肿瘤相关抗原NY-ESO-1。本研究旨在评估OVV-01在晚期实体瘤患者中的安全性、耐受性和疗效。
这是一项关于OVV-01在晚期实体瘤患者中的1期、首次人体、开放标签、多中心研究。OVV-01每两周（Q2W）瘤内注射一次，在第一剂后3周开始，共注射六剂。剂量递增采用3+3设计，共四个剂量水平，分别为6×10蚀斑形成单位（PFU）、6×10 PFU、6×10 PFU和1.2×10 PFU。主要终点是安全性和耐受性。次要终点包括根据实体瘤疗效评价标准第1.1版，由研究者评估的OVV-01的总缓解率（ORR）和疾病控制率（DCR）。
18名患者被纳入四个剂量组，其中6例为软组织肉瘤（STS）。未观察到剂量限制性毒性和与治疗相关的严重不良事件。11例患者接受了疗效评估，ORR为27.3%，DCR为63.6%。在4例可评估的晚期STS患者中，ORR为75%。2例STS患者在剂量高于6.0×10 PFU时达到完全缓解（CR）。
瘤内注射OVV-01在晚期实体瘤患者中安全且耐受性良好。在STS患者中观察到显著反应。
NCT04787003。
