DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 1, 2034

Study Completion Date

May 1, 2034

Conditions
High Grade GliomaAnaplastic Astrocytoma
Interventions
DRUG

DB107-RRV

Patients will undergo surgery to remove as much of the high-grade glioma (HHG) tumor as possible and will receive combination intravenous (IV) and adaptive repeat intratumoral delivery of DB107-RRV in the vein (IV) and in the walls of the cavity that remains where tumor is removed.

DRUG

DB107-FC

Patients will start taking DB107-FC three times by mouth every day for a period of seven days, which is one cycle of treatment. A cycle of treatment is medication taken on a set schedule with periods of rest in between. Patients will wait five weeks before taking the next seven day course of DB107-FC. The first dose of DB107-FC will be taken at the hospital or clinic; afterward, patients will take the doses of DB107-FC at home. Patients will take DB107-FC for up to 12 months after surgery.

Trial Locations (1)

33136

RECRUITING

University of Miami Hospital, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Denovo Biopharma LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Ashish Shah

OTHER

NCT06264388 - DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma | Biotech Hunter | Biotech Hunter