RecruitingPhase 1Phase 2NCT06504381

DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma

A Phase I/IIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination With DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma


Sponsor

University of California, San Francisco

Enrollment

70 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination of treatments — including two viral therapy agents (DB107-RRV and DB107-FC) — alongside standard radiation and chemotherapy for patients newly diagnosed with high-grade brain tumors (glioma or glioblastoma). Researchers want to see whether adding these new agents improves outcomes. **You may be eligible if...** - You are 18–75 years old with a newly diagnosed high-grade brain tumor (astrocytoma or glioblastoma) that has not yet been treated - Your tumor can be removed at least 80% through surgery - You are in reasonably good physical condition (Karnofsky score ≥70) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have previously received surgery, radiation, or chemotherapy for a brain tumor - You have a serious infection or uncontrolled medical condition - You are pregnant or breastfeeding - Your performance level is too low to safely undergo treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICDB107-RRV

Given intracranially (IC) during resection and intravenously (IV) immediately following

DRUGDB107-FC

Given orally (PO)

RADIATIONRadiation Therapy (RT)

Undergo RT

DRUGTemozolomide

Given PO

PROCEDUREMagnetic Resonance Imaging (MRI)

Undergo standard of care MRI

PROCEDURESurgical resection

Undergo non-investigational tumor resection


Locations(5)

University of Southern California

Los Angeles, California, United States

University of California, San Diego

San Diego, California, United States

University of California

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Northwell Health

Lake Success, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06504381


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