DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
Status:
RECRUITING
Trial end date:
2042-01-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Anova Enterprises, Inc California Institute for Regenerative Medicine (CIRM) Denovo Biopharma LLC
Treatments:
Flucytosine Magnetic Resonance Spectroscopy Radiotherapy Temozolomide vocimagene amiretrorepvec