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DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
NCT06504381 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature. This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase (MGMT) methylated patients or radiation therapy for MGMT unmethylated patients.
Conditions Studied
Interventions
- DRUG Temozolomide
- PROCEDURE Magnetic Resonance Imaging (MRI)
- RADIATION Radiation Therapy (RT)
- GENETIC DB107-RRV
- DRUG DB107-FC
Study Locations (5)
California
- University of Southern California — Los Angeles
- University of California, San Diego — San Diego
- University of California — San Francisco
Florida
- University of Miami — Miami
New York
- Northwell Health — Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-01-08 |
| Est. Completion | 2042-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06504381
The ClinicalTrials.gov registry entry for NCT06504381 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 5 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06504381 reports 5 study locations spanning 3 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06504381 about?
NCT06504381 is a clinical study titled "DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma". This is a multicenter, open-label study of DB107-RRV (formerly Toca 511) and DB107-FC (formerly Toca FC) when administered following surgical resection in newly diagnosed High Grade Glioma (HGG) patients. The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC...
What is the current status of trial NCT06504381?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2025-01-08. Estimated completion is 2042-01-31.
What conditions does trial NCT06504381 study?
This clinical trial studies the following conditions: High Grade Glioma, MGMT-Unmethylated Glioblastoma, MGMT-Methylated Glioblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06504381?
The interventions under investigation include: Temozolomide (DRUG), Magnetic Resonance Imaging (MRI) (PROCEDURE), Radiation Therapy (RT) (RADIATION), DB107-RRV (GENETIC), DB107-FC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06504381?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06504381 being conducted?
This trial has 5 study locations across California, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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