DNX-2401 for Metastatic Melanoma

This study is testing DNX-2401, an immunotherapy, for people with stage IV melanoma that has spread to the brain (intracranial) and/or other parts of the body (extracranial). The main goal is to find the safest and most effective dose and number of injections of DNX-2401. Researchers will also look at how well DNX-2401 works against the cancer. You might be able to join if you are 18 or older, have stage IV melanoma, and are generally able to perform daily activities (ECOG Performance status of 0 or 1). The study aims to enroll 50 participants.

Study design
This is an interventional study with an estimated enrollment of 50 participants. It is a dose-ranging, toxicity-seeking Phase 1 trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and adverse events (side effects) through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07444606

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:DNX-2401

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Melanoma
1 sites across 1 states
Texas1
  • Christopher Alvarez-Breckenridge, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Christopher Alvarez-Breckenridge, MD, PHD
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Depot or injectable birth control
IUD (Intrauterine Device)
Birth Control Patch (e.g., Othro Evra®)
NuvaRing®
Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)
WBC ≥3000/mm3
Platelets ≥100,000/ mm3
PT, INR or PTT \<1.5 x institutional upper limit
Hemoglobin \>8.0 g/dL
Total serum bilirubin ≤ 1.5 upper normal institutional limits
AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal; ≤5 ULN if there is liver involvement secondary to the tumor
Serum creatinine ≤ 1.5 x ULN OR
  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0