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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
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 moreTrial 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
547 Previous Clinical Trials
135,582 Total Patients Enrolled
8 Trials studying Sarcoma
220 Patients Enrolled for Sarcoma
Nancy Gady, BSStudy DirectorDNAtrix, Inc.
1 Previous Clinical Trials
49 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.The cancer has come back in the liver.You have been diagnosed with neuroendocrine tumor that has spread to the liver.Your liver enzymes (AST and/or ALT) or total bilirubin are more than 5 times the normal levels.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.If you are eligible for a specific treatment based on your gene mutations, you must have finished that treatment.You are allowed to have chemotherapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-level 2
- Group 2: Dose-level 3
- Group 3: Dose-level 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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