A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.

This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are: What is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial. What side effects are there of SGT-53 when it is used with radiation and Nivolumab? How does SGT-53 move through the body when given with radiation and Nivoluma

Trial Details

NCT ID
NCT07017816
Phase
EARLY_PHASE1
Sponsor
Children's National Research Institute
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • SGT-53
  • hypofractionated radiotherapy with immunotherapy
  • Nivolumab
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options.
  • i. Medulloblastoma, ATRT, High grade gliomas, pineoblastomas, embryonal tumors NOS, CNS sarcomas, ependymomas, other high-grade malignancies that f…
  • ii. Patients should have received radiation for standard up-front therapy. iii. Patients must have received at least one line of standard of care t…
  • c. Patients with metastatic disease are eligible d. Patients must have available archival (formalin-fixed paraffin embedded) or fresh tumor tissue …

For full eligibility, visit ClinicalTrials.gov.

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