MedTrace Logo

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

NCT06504381 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-11

No results posted yet for this 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

Interventions

GENETIC

DB107-RRV

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

DRUG

DB107-FC

Given orally (PO)

RADIATION

Radiation Therapy (RT)

Undergo RT

DRUG

Temozolomide

Given PO

PROCEDURE

Magnetic Resonance Imaging (MRI)

Undergo standard of care MRI

PROCEDURE

Surgical resection

Undergo non-investigational tumor resection

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Denovo Biopharma LLC

    collaborator INDUSTRY

  • Anova Enterprises, Inc

    collaborator INDUSTRY

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Nicholas Butowski, MD · University of California, San Francisco

  • Noriyuki Kasahara, MD, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2028-01-31
Completion
2042-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504381 on ClinicalTrials.gov