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NCT06504381 · ClinicalTrials.gov registry record · Phase 1
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
A Phase 1 study of High Grade Glioma and MGMT-Unmethylated Glioblastoma, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 5
- Study locations
NCT06504381: Recruiting Phase 1 study of High Grade Glioma and MGMT-Unmethylated Glioblastoma, sponsored by University of California, San Francisco.
NCT06504381 is a Phase 1 study of High Grade Glioma and MGMT-Unmethylated Glioblastoma that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 70 participants, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06504381, a Phase 1 study of High Grade Glioma and MGMT-Unmethylated Glioblastoma, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Tolerability is defined as the proportion of participants receiving at least one dose of DB107-RRV and DB107-FC with a reported dose-limiting toxicity for all participants in Phase I.
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 |
What NCT06504381 shows while recruiting
NCT06504381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target.
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.
NCT06504381 lists 5 locations in 3 states (California, Florida, New York).
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.
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).
Who is sponsoring clinical trial NCT06504381?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06504381's enrollment target sits among peer trials
70 7th of 42 higher than 36 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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