A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

Inclusion Criteria

• Patients or their legal representatives must be able to provide written informed consent.
• Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).
• Radiographic evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6 methyl guanyl-methyltransferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible.
• Human leukocyte antigen type HLA-A*02: 01, HLA-A*02:06, or HLA-A*24:02.
• Age ≥18.
• KPS score of ≥60.
• Serum creatinine value 40%. 17. Patient has a resting pulse oximetry of 90% or higher.

Exclusion Criteria

Patients with any of the following will be excluded from the study:

• Prior therapy with Bev.
• Patients with secondary GBM.
• Any anti-neoplastic therapy, including RT, for first relapse or recurrence.
• Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially.
• Evidence of impending herniation on imaging.
• Has known multifocal disease. Multifocal disease is defined as discrete sites of disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
• Patients with infections that have required treatment with systemic antibiotics within 7 days of first dose of protocol therapy.
• The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids.
• Treatment with any investigational agents within 5 half-lives of the agent in question or, if the half-life is unknown, within 28 days of enrollment.
• Pregnant or lactating females.
• Prior history of malignancy within 3 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening. (Patients with bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion.)
• Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen within 2 weeks of study enrollment.