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Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors

Study acronym: PED-DNX2401
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Site details revised at 2 of 2 sites
    v3
  2. Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from Apr 2029 to May 2029
    • Start date changed from estimate of Apr 2026 to May 12, 2026
    • Site contacts updated at 2 of 2 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07424092
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Collaborators: Princess Maxima Center for Pediatric Oncology, Asociación Española contra el Cáncer
Conditions
(from sponsor)		 High Grade Glioma, Ependymoma, Embryonal Tumor of Brain, Recurrence, Refractory, Pediatric, Young Adult
Related terms Ependymoma, Glioma, Recurrence
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov