A Phase 1/2 interventional study of DB107-RRV and DB107-FC in High Grade Glioma, MGMT-Unmethylated Glioblastoma and MGMT-Methylated Glioblastoma, sponsored by University of California, San Francisco. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by University of California, San Francisco · Phase 1/2, Interventional, and Treatment
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.
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 administered to newly diagnosed HGG patients (Phase I).
II. To evaluate radiographic response by Immunotherapy response assessment in neuro-oncology (iRANO) (Phase I).
III. To assess best overall response rates (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) and overall response rate (CR and PR) of each arm and subset (Phase IIa).
IV. To assess the duration of response of each arm and subset (Phase IIa). V. To assess the median overall PFS and PFS at month 6 (PFS-6) for each arm and subset (Phase IIa).
VI. To assess the median overall survival of each arm and subset (Phase IIa). VII. To evaluate the safety of DB107-RRV administered intracranially followed by IV DB107-RRV and DB107-FC (Phase IIa).
OUTLINE:
Participants will initially be enrolled in Phase I and treated with DB107-RRV intracranially, at time of surgical resection, and intravenously within 8 hours following surgery. Pathology will be performed locally as per standard practice to confirm participant's HGG diagnosis and Isocitrate dehydrogenase 1 (IDH1) mutation status. Participants in Phase I will then be assigned to one of 2 cohorts: No MGMT methylation (MGMT unmethylated) which will receive DB107-FC and RT following DB107-RRV or Low-High MGMT methylated which will receive DB107-FC, Temozolomide (TMZ) and RT following DB107-RRV. The safety and tolerability will be examined for the Phase I participants and RP2D dose confirmed. New participants will then be enrolled in Phase IIa under the established RP2D determined in Phase I, with the first 2 participants receiving a safety run-in at the RP2D. Once participant safety and tolerability are confirmed, additional participants will be enrolled in the Phase IIa portion of the study. All participants who receive DB107-RRV and DB107-FC will be followed for up to15 years.
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Each patient must meet all of the following inclusion criteria to be eligible for study entry:
Laboratory values adequate for patient to undergo surgery, including:
Female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30-days prior to the first administration of study drug, for the duration of study participation, and for 90-days following completion of the therapy. Should a female participant become pregnant or suspect a pregnancy while participating in this study, the treating physician must be informed immediately. IF a male participant impregnates or is suspected of impregnating a woman while participating in this study, the treating physician must be informed immediately.
Exclusion Criteria:
Participants may not meet any of the following exclusion criteria to be eligible for study entry:
A contrast-enhancing brain tumor that is any of the following:
Participants receive a 4.0 x 10\^8 transduction units per milliliter (TU/mL)) dose of DB107-RRV intracranially (IC) at resection and a 1.4 x 10\^9 TU/mL dose IV prior to leaving surgery room. Participants have up to 6 weeks for surgical recovery. Unmethylated MGMT participants receive 300 mg/kg/day DB107-FC PO during RT over 5 days during weeks 1-2, \& 5-6. 2 gray (Gy)/day standard of care (SOC) RT will be given for 5 consecutive days for 6 weeks. After RT, participants receive 1.4 x 10\^9 TU/mL of DB107-RRV IV on days 7 and 14 and continue during a 4-week rest period between RT and adjuvant therapy. Participants who begin adjuvant therapy receive 300 mg/kg/day DB107-FC PO on days 1-5 of a 28-day cycle up to 6 cycles or until PD. Participants with no PD during adjuvant treatment may receive additional cycles of DB107-FC until PD, withdrawal, death or study closure. Participants will be followed up for safety and survival status for up to 15 years.
Genetic: DB107-RRV · Drug: DB107-FC · Radiation: Radiation Therapy (RT) · Drug: Temozolomide · Procedure: Magnetic Resonance Imaging (MRI) · Procedure: Surgical resection
Participants receive a 4.0 x 10\^8 TU/mL dose of DB107-RRV IC at resection and a 1.4 x 10\^9 TU/mL dose IV prior to prior to leaving surgery room. Participants have up to 6 weeks for surgical recovery. Low to high MGMT methylation participants receive 75 mg/m\^2 TMZ per SOC and 300mg/kg/day DB107-FC PO concurrent with 2 Gy/day over 5 consecutive days during weeks 1-2, \& 5-6. After RT, participants receive 1.4 x 10\^9 TU/mL DB107-RRV IV on days 7 and 14. IV DB107-RRV occurs during a 4-week rest period between RT and adjuvant portions of the protocol. Participants who begin adjuvant therapy receive 300 mg/kg/day DB107-FC PO on days 1-5 of a 28-day cycle for up to 6 cycles or until PD with 150-200 mg/m\^2 adjuvant TMZ per SOC on days 1-5 of each cycle for up to 6 cycles. Participants with no PD may continue to receive additional cycles of DB107-FC PD, withdrawal, death or study closure. Participants will be followed up for safety and survival status for up to 15 years.
Genetic: DB107-RRV · Drug: DB107-FC · Radiation: Radiation Therapy (RT) · Drug: Temozolomide · Procedure: Magnetic Resonance Imaging (MRI) · Procedure: Surgical resection
Given intracranially (IC) during resection and intravenously (IV) immediately following
Also known as: Toca 511, Vocimagene amiretrorepvec
Given orally (PO)
Also known as: Toca FC, Extended-release 5-fluorocytosine, 5-fluorocytosine
Undergo RT
Also known as: Radiation Treatment
Given PO
Also known as: Temozolomide (TMZ)
Undergo standard of care MRI
Also known as: MR, MRI
Undergo non-investigational tumor resection
Also known as: Surgical tumor resection, Brain surgery
Proportion of participants with dose limiting toxicities (Phase I)
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.
Time frame: Up to 1 year
Proportion of participants with treatment-emergent adverse events (Phase I)
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.
Time frame: Up to 3 years
Median Progression free survival (PFS) by biomarker status (Phase IIa)
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.
Time frame: Up to 3 years
Recommended Phase 2 Dose (RP2D) (Phase I)
The confirmed RP2D of DB107-RRV and DB107-FC implemented for participants enrolled in Phase IIa will be reported.
Time frame: Up to 1 year
Overall Response Rate (ORR) (Phase IIa)
ORR is defined as the percentage of subjects who obtained either a disease status of CR or PR according to iRANO criteria per investigator.
Time frame: Up to 5 years
Median Progression-free survival (PFS) at 6 months (Phase IIa)
PFS is defined as time from first receipt of DB107-RRV until progression or death, whichever occurs first at the 6-month visit. 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.
Time frame: Up to 6 months
Median Progression-free survival (PFS) (Phase IIa)
PFS is defined as time from first receipt of DB107-RRV until progression or death, whichever occurs first at the 6-month visit. 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.
Time frame: 6 months
Median Overall Survival (OS) at 6 months (Phase IIa)
Overall survival at 6 months is defined as the time from the date of first DB107-RRV injection until death. Participants who are alive at 6 months will be censored. The median and the 95% confidence interval will be estimated using the Kaplan-Meier method.
Time frame: 6 months
Median Overall Survival (OS) (Phase IIa)
Overall survival will be analyzed using the date of first DB107-RRV injection as baseline until death, participant withdrawal, or study closure. The median and the 95% confidence interval will be estimated using the Kaplan-Meier method.
Time frame: Up to 15 years
Plan to share: Yes — De-identified data may be shared with study collaborators and research partners
Supporting information: Study protocol, Sap
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