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Virus Therapy

DNX-2440 for Liver Metastases from Colorectal Cancer

Phase 1
Waitlist Available
Research Sponsored by DNAtrix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial is testing an experimental virus called DNX-2440 to see if it is safe and effective in treating patients with liver metastasis who are scheduled for surgery.

Who is the study for?
Adults with multiple liver metastases from certain cancers (like colorectal, breast, or melanoma) who are candidates for surgery aimed at curing the disease. They must have finished any targeted therapy if applicable and be willing to follow study procedures. People with recurrent liver metastasis, more than 12 cycles of chemo for their liver metastasis, or on ongoing immunosuppressants can't join.Check my eligibility
What is being tested?
The trial is testing DNX-2440, an experimental virus designed to kill cancer cells. Patients will receive two injections into a liver tumor before having surgery to remove it. The study aims to find safe doses and see how the body responds across different dose levels before focusing on patients with colorectal cancer liver metastasis.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions related to immune activation such as fever, fatigue, flu-like symptoms and localized pain where the injection was given. As this is an experimental treatment, there could be unforeseen risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have cancer that has spread to your liver from certain types of cancer.
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You have two or more tumors in your liver.
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You are eligible for surgery with the intent to cure the disease.
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If you are eligible for a specific treatment based on your gene mutations, you must have finished that treatment.
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You are allowed to have chemotherapy before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) achieved during dose-escalation phase
Secondary outcome measures
Efficacy of DNX-2440 assessed by Tumor Regression Grade (TRG) score
Measure Immune response with ELISPOT
Measure Immune response with ImmunoSEQsec
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose-level 3Experimental Treatment1 Intervention
The dose-level 3 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
Group II: Dose-level 2Experimental Treatment1 Intervention
The dose-level 2 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
Group III: Dose-level 1Experimental Treatment1 Intervention
The dose-level 1 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.

Find a Location

Who is running the clinical trial?

DNAtrix, Inc.Lead Sponsor
7 Previous Clinical Trials
218 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
537 Previous Clinical Trials
134,961 Total Patients Enrolled
Nancy Gady, BSStudy DirectorDNAtrix, Inc.
1 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

DNX-2440 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04714983 — Phase 1
Periampullary Cancer Research Study Groups: Dose-level 1, Dose-level 2, Dose-level 3
Periampullary Cancer Clinical Trial 2023: DNX-2440 Highlights & Side Effects. Trial Name: NCT04714983 — Phase 1
DNX-2440 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04714983 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently searching for participants?

"Yes, the information on clinicaltrials.gov verifies that this trial is actively recruiting patients. Initially posted on February 15th 2021, it has been recently updated March 28th 2022 and seeks 30 participants from a single research site."

Answered by AI

Has DNX-2440 obtained regulatory clearance from the FDA?

"The safety of DNX-2440 was judged to be a 1 rating due to the limited evidence that exists in Phase 1 trials, which demonstrate only initial indications of efficacy and safety."

Answered by AI

How many people are currently participating in this research project?

"Affirmative, clinicaltrials.gov shows that this clinical trial is actively collecting participants since it was first posted on February 15th 2021, and the most recent update occurred March 28th 2022. A total of 30 patients are required for this single-site research project."

Answered by AI
~7 spots leftby Mar 2025