Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors
NCT07424092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2026-05-15
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
Conditions
- High Grade Glioma
- Ependymoma
- Embryonal Tumor of Brain
- Recurrence
- Refractory
- Pediatric
- Young Adult
Interventions
- BIOLOGICAL
-
DNX-2401
Single intratumoral infusion of 5 × 10\^10 viral particles of DNX-2401 after tumor biopsy.
Sponsors & Collaborators
-
Princess Maxima Center for Pediatric Oncology
collaborator OTHER -
Asociación Española contra el Cáncer
collaborator OTHER -
Clinica Universidad de Navarra, Universidad de Navarra
lead OTHER
Principal Investigators
-
Jaime Gállego Pérez de Larraya, M.D., Ph.D. · Cancer Center Clínica Universidad de Navarra
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-12
- Primary Completion
- 2029-05-31
- Completion
- 2029-05-31
- FDA Drug
- Yes
Countries
- Netherlands
- Spain
Study Locations
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