drugset
drugset / Trial / NCT06504381

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

NCT06504381 ↗

Phase 1/2 Recruiting 70 enrolled University of California, San Francisco Anova Enterprises, Inc · collabCalifornia Institute for Regenerative Medicine (CIRM) · collabDenovo Biopharma LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-08
Primary completion
2028-01-31
Completion
2042-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Flucytosine Small molecule 300 mg/kg Oral
Subject Vocimagene Amiretrorepvec Unknown 1.4e+09 unknown Other
Background Temozolomide Small molecule 75 mg/m2 Oral
Background Temozolomide Small molecule 150 mg/m2 Oral
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications

glioblastoma