DNX-2440 for Resectable Colorectal Liver Metastasis

Summary

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.

Timeline

Start

2021-02-15

Primary completion

2026-07-31

Completion

2026-12-31

Outcome

Outcome not reported

Stopped: “DNAtrix management decision not based on study design, safety, or site performance.”

Drugs

Indications