IDOV-Safe: An intravenously deliverable oncolytic vaccinia virus for solid tumors refractory to standard of care—preliminary results from the pMMR/MSS CRC cohort.

作者：Tong Xie, Zhenghang Wang, Ting Xu, Changsong Qi, Jifang Gong, Nanhai G. Chen, Xiang Deng, Jian Li, Lin Shen · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.e15556 · 被引用次数：1 · 研究领域：Virus-based gene therapy research、Cancer Research and Treatments、Viral Infectious Diseases and Gene Expression in Insects

e15556 Background: Metastatic pMMR/MSS colorectal cancer (CRC) remains challenging to treat following progression on oxaliplatin- and irinotecan- based therapies, with limited responsiveness to PD-1/PD-L1 inhibitors. Oncolytic viruses (OVs) offer a promising new approach to bio-immunotherapy for solid tumors. However, no effective OV therapy for MSS CRC has been reported to date. IDOV-Safe is a first-in-class, intravenously deliverable oncolytic vaccinia virus with potential against MSS CRC. Here, we present the first-in-human results from a phase I clinical trial evaluating the safety, PK, PD and preliminary efficacy of intravenous IDOV-Safe in the MSS CRC cohort, and also investigates potential combination strategies to enhance therapeutic outcomes. Methods: Only pMMR/MSS metastatic CRC patients who have failed from at least two lines of systematic therapy (including both oxaliplatin and irinotecan-based regimens) will be included in the study. In the dose-escalation phase, a “3+3” design was used to determine the dose-limiting toxicity (DLT) and maximum tolerated dose across four dose levels: 1×10 9 , 3×10 9 , 1×10 10 and 3×10 10 PFUs. For rapid dose titration, only one patient was enrolled at the first dose level. In the safety expansion phase, one or two dose levels will be selected, with 6-12 patients enrolled at each level. During this phase, patients who experience progression on IDOV-Safe monotherapy will transition to combination therapy with IDOV-Safe, Toripalimab ...