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NCT07017816 · ClinicalTrials.gov registry record · Early Phase 1
A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.
A Early Phase 1 study, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT07017816 is a Early Phase 1 study that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 18 participants.
The verdict
NCT07017816, a Early Phase 1 study, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
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 Nivolumab? How much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients? Participants will: For the first treatment cycle: Get SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2 For Cycles 2-6: Get SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.
Interventions
- DRUG Nivolumab
- DRUG SGT-53
- RADIATION hypofractionated radiotherapy with immunotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-12-16 |
| Est. Completion | 2028-05-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07017816
The ClinicalTrials.gov registry entry for NCT07017816 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT07017816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07017816 about?
NCT07017816 is a clinical study titled "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-5...
What is the current status of trial NCT07017816?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2025-12-16. Estimated completion is 2028-05-01.
What interventions are being tested in trial NCT07017816?
The interventions under investigation include: Nivolumab (DRUG), SGT-53 (DRUG), hypofractionated radiotherapy with immunotherapy (RADIATION).
Who is sponsoring clinical trial NCT07017816?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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