DNX-2440 for Liver Metastases from Colorectal Cancer
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: DNAtrix, Inc.
No Placebo Group
Trial Summary
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
JR
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.
Male or female aged ≥ 18 years at time of consent
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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.
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Treatment Details
Interventions
- DNX-2440 (Virus Therapy)
Trial OverviewThe 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
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 Clinic Near You
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+