NCT06504381 · University of California, San Francisco
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
What this study is about
This is a conducted at multiple hospitals, where both patients and doctors know the treatment given 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.
View original scientific description
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.
Interventions
GENETIC
DB107-RRV
Given intracranially (IC) during resection and intravenously (IV) immediately following
DRUG
DB107-FC
Given orally (PO)
RADIATION
Radiation Therapy (RT)
Undergo RT
DRUG
Temozolomide
Given PO
PROCEDURE
Magnetic Resonance Imaging (MRI)
Undergo standard of care MRI
PROCEDURE
Surgical resection
Undergo non-investigational tumor resection
Primary outcome measures
Proportion of participants with dose limiting toxicities (Phase I)
Time frame: Up to 1 year
Tolerability is defined as the proportion of participants receiving at least one dose of DB107-RRV and DB107-FC with a reported dose-limiting toxicity for all participants in Phase I.
Proportion of participants with treatment-emergent adverse events (Phase I)
Time frame: Up to 3 years
Safety is defined as the proportion of participants with treatment-emergent adverse events as classified by the Medical Dictionary for Regulatory Activities (MEDDRA) preferred terms and graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for participants in Phase 1.
Median Progression free survival (PFS) by biomarker status (Phase IIa)
Time frame: Up to 3 years
PFS is defined as time from first receipt of DB107-RRV until progression or death, whichever occurs first for newly diagnosed HGG patients with unmethylated MGMT and methylated MGMT. Participants without an event will be censored at the last disease assessment. PFS (months) = (earlier date of documentation of progression of disease or death/censored - date of first dose of DB107-RRV+1) (365.25/12) using Immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria to determine disease status. The median and the 95% confidence interval will be estimated using the Kaplan-Meier method.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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-wildtype). 5. Based on the pre-operative evaluation by neurosurgeon, participant is a candidate for \>= 80% resection of the enhancing region. 6. The primary tumor must be made available for central testing for IDH1 mutation, O6-methylguanine-DNA methyl-transferase (MGMT) methylation status. 7. Willing to provide a blood sample to determine Denovo Genomic Marker 7 (DGM7) status. 8. Laboratory values a
Where
- Los Angeles, California
- San Diego, California
- San Francisco, California
- Miami, Florida
- Lake Success, New York
Collaborators
California Institute for Regenerative Medicine (CIRM), Denovo Biopharma LLC, Anova Enterprises, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations