The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.
Patients 18-75 years old.
Histologically proven HGG that have recurred/progressed (first or second recurrence).
Patients with unresectable or resectable HGG (AA or GBM) will be enrolled.
Measurable disease on MRI as evidenced by 1 cm on two separate dimensions on MRI fluid attenuated inversion recovery (FLAIR) (non-enhancing) or contrast-enhancement.
History of active other malignancy (other than non-melanoma skin cancers, cervical ductal carcinoma in situ or localized prostate cancer) within 5 years.
Multifocal gliomas that cannot undergo stereotactic biopsy/administration of DB107-RRV will be excluded. Patients with 3 or more intracranial recurrences will be excluded.
Histologically confirmed oligodendroglioma or mixed gliomas.
History of human immunodeficiency virus (HIV) infection or other forms of severe immunosuppression.
Ashish Shah
Lead sponsor
University of Miami
Sponsor institution
Denovo Biopharma LLC
Collaborator
National Cancer Institute (NCI)
Collaborator