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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, San Francisco
Study ID
NCT06504381
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • High Grade Glioma
  • MGMT-Methylated Glioblastoma
  • MGMT-Unmethylated Glioblastoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DB107-RRV — GENETIC
    Given intracranially (IC) during resection and intravenously (IV) immediately following
  • DB107-FC — DRUG
    Given orally (PO)
  • Radiation Therapy (RT) — RADIATION
    Undergo RT
  • Temozolomide — DRUG
    Given PO
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Undergo standard of care MRI
  • Surgical resection — PROCEDURE
    Undergo non-investigational tumor resection

Study Details

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.

Key Dates

Start date
Jan 8, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2042

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: No MGMT Methylation (DB107-RRV, DB107-FC, Radiation therapy)
    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.
  • Experimental: Low to High MGMT Methylation (DB107-RRV, DB107-FC, Temozolomide (TMZ), Radiation therapy)
    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.

Primary Outcome Measure

Proportion of participants with dose limiting toxicities (Phase I) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90089
[email protected]
(323) 409-7422
Thomas Chen, MD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoSan DiegoCalifornia92093
[email protected]
858-822-5354
David Piccioni, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of CaliforniaSan FranciscoCalifornia94143
Stephanie Lewis, RN
[email protected]
(415) 353-2193
Neuro-Oncology New Patient Coordinator
[email protected]
Nicholas Butowski, MD (PRINCIPAL_INVESTIGATOR)
Noriyuki Kasahara, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
[email protected]
(305) 243-0864
Ashish Shah, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthLake SuccessNew York11042
[email protected]
516-941-1260
Samuel Singer, MD (PRINCIPAL_INVESTIGATOR)

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