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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DNX-2440 for individuals with liver tumors from colorectal cancer. The goal is to determine if DNX-2440 is safe and effective when injected directly into liver tumors before surgery. Participants will receive two injections of DNX-2440 to identify the optimal dose before surgery. This trial suits those with at least two liver tumors, scheduled for surgical removal, and who have completed any necessary targeted therapy. As a Phase 1 trial, participants will be among the first to receive DNX-2440, aiding researchers in understanding how this new treatment works in people.

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.

Is there any evidence suggesting that DNX-2440 is likely to be safe for humans?

Research has shown that DNX-2440 is a new treatment being tested to attack and destroy cancer cells in the liver. As this is an early-stage study, limited safety information is available. The primary goal at this stage is to assess safety, so researchers closely monitor any side effects.

Since DNX-2440 remains under study, detailed safety results have not been widely shared. This treatment lacks approval for other uses, so no FDA safety information is available. The study tests various doses to determine a safe amount for patients, and researchers manage any side effects to ensure patient safety.

Prospective participants should consult their doctor to understand the potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DNX-2440 because it offers a novel approach to treating liver metastases from colorectal cancer. Unlike traditional treatments like chemotherapy, which target rapidly dividing cells throughout the body, DNX-2440 is delivered directly into the tumor via intra-tumoral injection. This localized delivery method allows the treatment to act directly where it's needed, potentially reducing side effects and enhancing effectiveness. Additionally, DNX-2440 utilizes a viral vector to selectively target cancer cells, providing a promising new mechanism of action that could improve outcomes for patients who do not respond well to existing therapies.

What evidence suggests that DNX-2440 might be an effective treatment for liver metastases from colorectal cancer?

Research has shown that DNX-2440 is a specialized virus engineered to target and destroy cancer cells. Early findings suggest that DNX-2440 infects liver cancer cells, causing them to burst and potentially shrink tumors. It may also enhance the immune system's ability to attack cancer cells. Although human studies provide limited information, this method has shown promise in lab tests for treating liver cancer that has spread from colorectal cancer. The trial will evaluate DNX-2440 at various dose levels to better understand its potential benefits and effectiveness in real patients. ^{1 4 5 6 7}

Who Is on the Research Team?

Joan Robbins, Ph.d

Principal Investigator

DNAtrix, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04714983/dnx-2440-for-resectable-colorectal-liver-metastasis

DNX-2440 for Resectable Colorectal Liver Metastasis The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04714983

DNX-2440 for Resectable Colorectal Liver Metastasis The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, ...

3. omicsdi.org omicsdi.org/dataset/ecrin-mdr-crc/2364327

DNX-2440 for Resectable Colorectal Liver Metastasis ABSTRACT: The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) ...

4. withpower.com withpower.com/trial/phase-1-carcinoma-renal-cell-1-2021-48b54

DNX-2440 for Liver Metastases from Colorectal Cancer This trial tests DNX-2440, a virus designed to kill cancer cells, in patients with multiple liver tumors who are undergoing surgery.

5. biospace.com biospace.com/dnatrix-announces-first-patient-dosed-in-clinical-study-of-dnx-2440-an-ox40-ligand-expressing-immunotherapy-in-colorectal-cancer-and-other-cancers-with-liver-metastasis

DNAtrix Announces First Patient Dosed in Clinical Study of ... This two-part clinical study is designed to directly demonstrate the activity of DNX-2440 and potential as therapy for colorectal cancer, as ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2021-00608

DNX-2440 for Resectable Colorectal Liver Metastasis - NCI The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis.

7. onclive.com onclive.com/view/dnx-2440-shows-promise-in-crc-and-other-cancers-with-liver-metastasis-as-phase-1-trial-begins

DNX-2440 Shows Promise in CRC and Other Cancers ... Investigation into a novel oncolytic adenovirus as a treatment option for patients with colorectal cancer and other cancers with liver metastasis is underway.