What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as trabectedin and doxorubicin, have been associated with side effects including fatigue, elevated liver transaminases, diarrhea, and nausea. In a study combining sirolimus with ganetespib, the most frequent non-dose-limiting toxicities were diarrhea, elevated liver transaminases, and fatigue. These side effects are typical of advanced cancer therapies, which often aim to balance efficacy with manageable toxicity profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoma, including targeted therapies and chemotherapeutic agents. Notably, pazopanib, a tyrosine kinase inhibitor, has been approved for the treatment of advanced soft tissue sarcoma. Additionally, eribulin mesylate has shown activity in patients with advanced liposarcoma and leiomyosarcoma. While there is no specific mention of FDA-approved oncolytic adenoviruses for sarcoma in the provided context, these approvals highlight the ongoing efforts to develop effective treatments for various subtypes of sarcoma.

What other types of research exist?

Promising novel alternatives to DNX-2440 for sarcoma patients in 2024 include: 1) Pembrolizumab (Keytruda) - an immune checkpoint inhibitor that has shown efficacy in various sarcomas, particularly those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 2) Atezolizumab plus Bevacizumab - a combination of an immune checkpoint inhibitor and an anti-angiogenic agent, which has shown promise in renal cell carcinoma and may be applicable to sarcomas. 3) Avelumab plus Axitinib - another combination of an immune checkpoint inhibitor and a tyrosine kinase inhibitor, which has shown efficacy in renal cell carcinoma with sarcomatoid features and may be considered for sarcoma treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

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.

Do I qualify?Apply below to find out

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.

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