DNX-2440 for Resectable Colorectal Liver Metastasis

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.

本研究旨在针对拟接受根治性肝切除手术的可切除多灶性（病灶数≥2个）肝转移患者，评估一款名为DNX-2440的实验性溶瘤腺病毒（Oncolytic Adenovirus）。研究计划招募最多18名患者，在肝切除术前，对其1枚肝转移瘤实施两次序贯瘤内注射DNX-2440，以在3个剂量梯度（剂量爬坡阶段）中评价安全性与生物学终点。待剂量爬坡阶段结束后，将选取安全且生物学适配性良好的剂量，沿用相同给药方案，为额外12例结直肠癌肝转移患者（扩展队列）给药，并采用既定生物学终点完成后续评估。