DNX-2440 for Liver Metastases from Colorectal Cancer

Overseen By Joan Robbins, Ph.d

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: DNAtrix, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Neuroendocrine tumors, Organ dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy, you may not be eligible to participate.

What is the purpose of this trial?

This trial tests DNX-2440, a virus designed to kill cancer cells, in patients with multiple liver tumors who are undergoing surgery. The treatment involves injecting the virus directly into the tumors to shrink them before they are removed. The goal is to determine the safest and most effective dose for these patients, including those with colorectal cancer that has spread to the liver.

Research Team

Joan Robbins, Ph.d

Principal Investigator

DNAtrix, Inc.

Eligibility Criteria

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.

Inclusion Criteria

You have cancer that has spread to your liver from certain types of cancer.

You have two or more tumors in your liver.

You are eligible for surgery with the intent to cure the disease.

Exclusion Criteria

You have liver cancer that has been treated with more than 12 cycles of systemic chemotherapy.

You are currently taking medication that weakens your immune system.

Your lab tests show that your organs are not working well enough.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery, approximately 14 days apart

4 weeks

2 visits (in-person)

Surgery

Participants undergo curative-intent liver resection surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including immune response and tumor regression assessments

3 years

Treatment Details

Interventions

• DNX-2440

Trial Overview 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.

Participant Groups

Group I: Dose-level 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

DNAtrix, Inc.

Lead Sponsor

Trials

8

Recruited

250+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+