🏛️ Verified NIH Record • Updated 2026-04-30

Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases (NCT07444606)

🟡 Not Yet Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical research study is to find the recommended dose level and recommended number of injections of the study agent DNX-2401 that can be given to patients with metastatic melanoma that have intracranial and/or extracranial lesions.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (34 items) and avoid the listed exclusions (8 items).

Location: The University of Texas M. D. Anderson Cancer Center — Houston, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria (For Both Groups):
  • Patients with \>5 diagnosed intracranial metastases on screening MRI
  • Patients who received prior WBRT or SRT for brain metastases within 2 days of study treatment initiation
  • Patients with symptomatic intracranial metastases
  • Patients who received high dose corticosteroids defined as dexamethasone greater than 2mg per day within 7 days of initiating therapy. However, if they have been on a stable dose of 2 mg or less per day for 7 days they can be enrolled.
  • Patients with suspected or confirmed leptomeningeal disease defined as radiographic evidence by MRI of leptomeningeal involvement in addition to positive cerebrospinal fluid (CSF) cytology
  • Serum lactate dehydrogenase ≥1.5x upper limit of normal
  • Primary uveal or mucosal melanoma 8 Patients who are checkpoint inhibitor naïve. 9 Active uncontrolled infection or unstable or severe intercurrent medical conditions which would impact the ability to participate in the study. All patients must be afebrile at baseline and not taking antiviral or oral antibiotics. 10\. Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued, based on the clinical judgment of the surgeon, prior to oncolytic viral administration, the patient may be eligible. 11\. Past radiation or surgical therapy to the index lesion is exclusionary. However, up to a total of 2 prior courses of radiation treatment or surgical resection to non-index lesions are allowed as long as any treated lesions were \>15mm from the index lesion. 12\. Known infections with hepatitis B (positive HBsAg), hepatitis C (positive hepatitis C RNA), or HIV 13\. Patients with known or suspected immunosuppressive disorders, such as acquired or congenital/immune deficiency syndromes and autoimmune diseases 14\. Tumor position that, in the Investigator's opinion, would require ventricular, brainstem or posterior fossa injection in order to deliver the virus 15\. Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc. 16\. Inoculation with a live vaccine within 30 days prior to oncolytic virus administration 17\. History of encephalitis, multiple sclerosis, other CNS infection or primary CNS disease that would interfere with subject evaluation 18\. Females who are pregnant or lactating females who are breastfeeding

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • The University of Texas M. D. Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗