Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intrac… (NCT07444606) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
United States50 participantsStarted 2026-08-31
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.Patients must be able to complete an MRI of the head with contrast. 5.For women of childbearing potential only, a negative urine or serum pregnancy test is required at screening. Women must agree to notify investigator immediately if they become pregnant at any time during the trial period.
.Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 6 months from administration of virus. Birth control that is acceptable to use in this study:
.Patients must be able and willing to provide informed consent. A legally authorized representative (LAR) may provide consent if the potential subject lacks the capacity to provide consent themselves. Patient assent will be sought where feasible in this situation.
.- For patients enrolled in Groups A and B, patients must be relapsed or refractory to standard of care therapy. Additionally, patients must continue with immunotherapy while undergoing oncolytic viral treatment at the discretion of the medical oncologist. 9. Patients enrolled in Group A or Group B must be on one of the following FDA approved immunotherapy agents: Ipilimumab, Nivolumab, Pembrolizumab, Relatlimab.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Patients must have radiographic evidence of stable extracranial disease or no evidence of extracranial disease on current immunotherapy regimen based on RECIST v1.1 criteria.
. Patients must have between one and five brain metastases secondary to intracranial disease progression, identified on the screening MRI, from histologically confirmed metastatic melanoma. At least one of those lesions must be untreated, be suitable for accurate repeated measurements and have a tumor diameter of either 1.0-3.5cm (Group A- Arm 1) or 1.0-2.0cm (Group A- Arm 2) on the screening magnetic resonance imaging \[MRI\]) in at least one dimension. One of those lesions will be designated as the index lesion and planned for stereotactic intraoperative biopsy to ensure viable tumor tissue and oncolytic viral administration. The other four may be newly diagnosed, stable or recurrent.
. All intracranial metastases (the index lesion, and the non-index lesions, as defined below) must be located \>5 mm from the optic chiasm and outside the brainstem.
. The brain metastases must be an independently verified measurable brain metastasis in accordance with the mRECIST (Appendix 1) by Neuro Radiology.
Exclusion criteria
. 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