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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
No Placebo-Only Group

Summary

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.

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.
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.
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 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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sarcoma include surgery, radiation therapy, and chemotherapy. Surgery involves physically removing the tumor, radiation therapy uses high-energy rays to kill cancer cells, and chemotherapy employs drugs to target and destroy cancer cells. Oncolytic adenoviruses like DNX-2440 represent a novel approach, where the virus selectively infects and kills cancer cells while stimulating an anti-tumor immune response. Understanding these mechanisms is crucial for sarcoma patients as it helps in selecting the most effective treatment strategy, potentially improving outcomes and minimizing side effects.
Cure in Advanced Renal Cell Cancer: Is It an Achievable Goal?Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).Fifty years of advances in sarcoma treatment: moving the needle from conventional chemotherapy to targeted therapy.

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
559 Previous Clinical Trials
144,543 Total Patients Enrolled
8 Trials studying Sarcoma
219 Patients Enrolled for Sarcoma
Joan Robbins, Ph.dStudy DirectorDNAtrix, Inc.

Media Library

DNX-2440 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04714983 — Phase 1
Sarcoma Research Study Groups: Dose-level 2, Dose-level 3, Dose-level 1
Sarcoma 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
~10 spots leftby Jul 2026