A Phase I/IIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination With DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma
University of California, San Francisco
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.
Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of DB107-RRV administered intracranially followed by intravenous (IV) DB107-RRV and DB107-FC (Phase I). II. To determine the median progression-free survival (PFS) (informed by biomarker status, DGM7 and patient subsets to minimally include genomic profile and histology) of newly diagnosed HGG patients treated with DB107-RRV combined with DB107-FC delivered with standard of care following tumor resection (Phase IIa). SECONDARY OBJECTIVES: I. To confirm the recommended Phase 2 Dose (RP2D) of DB107-RRV and DB107-FC when administe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be eligible for study entry: 1. Participant has provided written informed consent. 2. Participant is between 18 years of age and 75 years of age, inclusive. 3. Participant must have a Karnofsky Performance Scale (KPS) of \>= 70. 4. Participant must have newly diagnosed adult-type diffuse gliomas (World Health Organization Classification 2021) that has not been previously treated with surgery, radiation or chemotherapy (specifically astrocytoma, Isocitrate dehydrogenase (IDH)-mutant or glioblastoma, IDH-wild…
Interventions
- GeneticDB107-RRV
Given intracranially (IC) during resection and intravenously (IV) immediately following
- DrugDB107-FC
Given orally (PO)
- RadiationRadiation Therapy (RT)
Undergo RT
- DrugTemozolomide
Given PO
- ProcedureMagnetic Resonance Imaging (MRI)
Undergo standard of care MRI
- ProcedureSurgical resection
Undergo non-investigational tumor resection
Locations (5)
- University of Southern CaliforniaLos Angeles, California
- University of California, San DiegoSan Diego, California
- University of CaliforniaSan Francisco, California
- University of MiamiMiami, Florida
- Northwell HealthLake Success, New York