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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 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.

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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.

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

FieldValue
Enrollment Target 70 participants
Start Date 2025-01-08
Est. Completion 2042-01-31
Phase Phase 1

What the Registry Record Tells You About NCT06504381

The ClinicalTrials.gov registry entry for NCT06504381 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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