Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors
The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401. The main questions it aims to answer are: * Does a single intratumoral administration of D
| Condition(s) | High Grade Glioma, Ependymoma, Embryonal Tumor of Brain, Recurrence, Refractory, Pediatric, Young Adult |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401. The main questions it aims to answer are: * Does a single intratumoral administration of DNX-2401 elicit tumor response and improve survival? * Is a single intratumoral administration of DNX-2401 safe and well tolerated? Participants will: * Undergo surgery for tumor biopsy followed by a single intratumoral administration of DNX-2401 * Visit the clinic periodically for checkups and tests |
| Who can participate | Inclusion Criteria: * The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides writ-ten assent, where applicable, based on age and country requirements. * Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors \[medulloblastomas, ATRT, EMTR, pineoblastoma\], and ependymomas) diagnosis based on initial histopathological diagnosis and further clinical and radiological fol-low-up, in whom gross total resection is not feasible, and with a life expectancy of at least 16 weeks at the time of consent. * Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecu |
| Ages | 1 Year to 25 Years |
| Sex | All |
| Lead sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
| Locations | Utrecht, Netherlands; Pamplona, Navarre, Spain |
| Start date | 2026-05-12 |
| NCT ID | NCT07424092 |
| Official listing | https://clinicaltrials.gov/study/NCT07424092 |