Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme

Inclusion criteria

• Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
• Measurable disease by RANO criteria;
• Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
• An interval of at least 4 weeks between prior surgical resection and study enrollment;
• An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
• Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
• Karnofsky performance status > 60%

Exclusion criteria

• Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
• Prior stereotactic radiotherapy;
• Active infection;
• Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
• Subjects who suffered from an acute cardiac event within the last 12 months;
• Subjects with active vascular disease, either myocardial or peripheral;
• Subjects with proliferative and/or vascular retinopathy;
• Subjects with known active second malignancy;