Study of DB107-RRV and DB107-FC for High Grade Glioma
This study is testing DB107-RRV and DB107-FC, along with standard treatments like radiation and temozolomide, for people with newly diagnosed High Grade Glioma (a type of brain cancer). DB107-RRV is given directly into the brain during surgery and then into a vein, while DB107-FC is taken by mouth. Researchers want to see if adding these treatments improves how long people live without their cancer getting worse and how safe they are. You may be able to join if you are between 18 and 75 years old, have a good performance status (Karnofsky Performance Scale of >= 70), and have High Grade Glioma. The study will look at side effects and how well the treatment works over time.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It aims to enroll 70 participants.
- What's involved
- You would undergo surgical resection, receive DB107-RRV (intracranially and intravenously), take DB107-FC orally, and have radiation therapy and potentially temozolomide. You would also have standard Magnetic Resonance Imaging (MRI) scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 3 years and how long participants live without the cancer progressing for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma
At a glance
Conditions
Where it's being run
5 sites across 3 statesStudy leadership
- Nicholas Butowski, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Noriyuki Kasahara, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Proportion of participants with dose limiting toxicities (Phase I)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)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)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.