OncoMatch/Clinical Trials/NCT06504381
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
Is NCT06504381 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DB107-FC and Temozolomide for high grade glioma.
Treatment: DB107-FC · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
central testing for IDH1 mutation
Required: MGMT methylation status
central testing for ... O6-methylguanine-DNA methyl-transferase (MGMT) methylation status
Disease stage
Grade: high (WHO 2021)
newly diagnosed adult-type diffuse gliomas (World Health Organization Classification 2021)
Prior therapy
Cannot have received: surgery
has not been previously treated with surgery
Cannot have received: radiation therapy
has not been previously treated with ... radiation
Cannot have received: chemotherapy
has not been previously treated with ... chemotherapy
Cannot have received: Gliadel wafer (Gliadel wafer)
Exception: received < 30 days from Cycle 1: Day 1
intends to undergo treatment with the Gliadel® wafer at the time of resection surgery or has received Gliadel® wafer < 30 days from Cycle 1: Day 1
Lab requirements
Blood counts
Platelet count >= 60,000/mm^3; Hemoglobin >= 10 g/dL; Absolute neutrophil count (ANC) >= 1,500/mm^3; Absolute lymphocyte count >= 500/mm^3
Kidney function
Estimated glomerular filtration rate of at least 50 mL/min by Cockcroft Gault Formula
Liver function
Total bilirubin <=1.5 x ULN (unless patient had Gilbert's syndrome); ALT <= 2.5 x ULN
Laboratory values adequate for patient to undergo surgery, including: Platelet count >= 60,000/mm^3; Hemoglobin >= 10 g/dL; Absolute neutrophil count (ANC) >= 1,500/mm^3; Absolute lymphocyte count >= 500/mm^3; Total bilirubin <=1.5 x upper limit of normal (ULN) (unless patient had Gilbert's syndrome); alanine aminotransferase (ALT) <= 2.5 x ULN; Estimated glomerular filtration rate of at least 50 mL/min by Cockcroft Gault Formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Southern California · Los Angeles, California
- University of California, San Diego · San Diego, California
- University of California · San Francisco, California
- University of Miami · Miami, Florida
- Northwell Health · Lake Success, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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