SuspendedPhase 1

DNX-2440 for Resectable Colorectal Liver Metastasis

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

United States30 participantsStarted 2021-02-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Male or female aged ≥ 18 years at time of consent * Diagnosis of liver metastases from colorectal, breast, gastric, periampullary, melanoma, renal cell cancer, sarcoma, squamous cell carcinoma or gastrointestinal stromal tumor * Multiple (≥ 2) liver tumors * Candidate for curative-intent surgery * Stated willingness to comply with all study procedures and availability for the duration of the study. * Candidates eligible for targeted therapy, as per standard of care guidelines (and based on mutational status as indicated), must have completed therapy * Preoperative chemotherapy is allowed Key Exclusion Criteria: * Recurrence of liver metastasis * Diagnosis of neuroendocrine tumor liver metastasis * Liver metastasis treated with \> 12 cycles of systemic chemotherapy * Condition that requires ongoing systemic immunosuppressive therapy * Evidence of inadequate organ function based on lab parameters * Liver transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) or total bilirubin \> 5x the upper limits of normal * Males or females who refuse to use a double-barrier form of birth control during the study and for up to 6 months after injection with DNX-2440

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose (MTD) achieved during dose-escalation phase

Timeframe: 1.5 Years

Trial details

NCT IDNCT04714983

SponsorDNAtrix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Liver Metastases trials