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

Starting soon · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID: NCT07444606
Run by: M.D. Anderson Cancer Center
People needed: 50
Starts: 2026-08-31
Expected to finish: 2029-01-30
Last updated by the study team: 2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

(For both Groups):
Patients must be 18 years old or older. 2. Patients must have a diagnosis of stage IV melanoma. 3.Patients must have an ECOG Performance status of 0 or 1 (may be obtained from medical records within 24 days of screening if not performed at screening).
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:
Using twice the normal protection of birth control (i.e., double barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier method (e.g., condom or diaphragm)
Birth control pills ("The Pill")
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)
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.
Normal hematologic, renal and liver function as defined by:
ANC ≥1000/ mm3
AGC ≥1500/ mm3
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
≥40 mL/min for participant with creatinine levels > 1.5 x institutional ULN
(For Group A):

You may not qualify if…

(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.
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.
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.
Known infections with hepatitis B (positive HBsAg), hepatitis C (positive hepatitis C RNA), or HIV
Patients with known or suspected immunosuppressive disorders, such as acquired or congenital/immune deficiency syndromes and autoimmune diseases
Tumor position that, in the Investigator's opinion, would require ventricular, brainstem or posterior fossa injection in order to deliver the virus
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.
Inoculation with a live vaccine within 30 days prior to oncolytic virus administration
History of encephalitis, multiple sclerosis, other CNS infection or primary CNS disease that would interfere with subject evaluation
Females who are pregnant or lactating females who are breastfeeding

Where it is running

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

Full record on ClinicalTrials.gov

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