Actively Recruiting
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
Led by University of California, San Francisco · Updated on 2026-03-11
70
Participants Needed
5
Research Sites
890 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Between 18 and 75 years of age
- Karnofsky Performance Scale (KPS) score of 70 or higher
- Newly diagnosed adult-type diffuse gliomas (astrocytoma, IDH-mutant or glioblastoma, IDH-wildtype) with no prior surgery, radiation, or chemotherapy
- Candidate for at least 80% resection of the enhancing tumor region
- Primary tumor available for IDH1 mutation and MGMT methylation testing
- Willing to provide blood sample for Denovo Genomic Marker 7 (DGM7) status
- Adequate lab values for surgery including platelet count ≥ 60,000/mm³, hemoglobin ≥ 10 g/dL, ANC ≥ 1,500/mm³, lymphocytes ≥ 500/mm³, bilirubin ≤1.5 x ULN (unless Gilbert's syndrome), ALT ≤ 2.5 x ULN, and estimated glomerular filtration rate ≥ 50 mL/min
- Agree to use effective contraception for 30 days before first study drug dose, during study, and for 90 days after therapy completion if of child-bearing potential or male
- Not breastfeeding
- Ability and willingness to comply with study schedule and requirements
You will not qualify if you...
- Prior treatment for High Grade Glioma
- History of other cancers unless disease-free for 5 years (except treated basal cell or squamous skin cancer, localized prostate carcinoma, or cervical carcinoma in situ)
- Histologically confirmed oligodendroglioma or mixed glioma
- Brain tumor that is multi-focal, has diffuse subependymal or leptomeningeal spread, or is larger than 5 cm in any dimension
- Active infection requiring treatment within 4 weeks before study start
- Bleeding disorders or need for anticoagulants or antiplatelet drugs that cannot be stopped for surgery
- HIV positive
- Hepatitis B, Hepatitis C, or co-infection
- Allergy or intolerance to flucytosine (DB107-FC)
- Gastrointestinal disease preventing swallowing or absorption of DB107-FC
- Use or planned use of Gliadel wafer within 30 days before study
- Severe lung, heart, or other systemic disease preventing surgery
- Any other condition that may affect compliance or increase treatment risk per investigator assessment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
3
University of California
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
Research Team
S
Stephanie Lewis, RN
CONTACT
N
Neuro-Oncology New Patient Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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