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

• Status: Completed
• Trial end date: 2018-12-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;

2. Measurable disease by RANO criteria;

3. Disease progression or recurrence following standard of care treatment with temozolomide and radiation;

4. An interval of at least 4 weeks between prior surgical resection and study enrollment;

5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;

6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;

7. Karnofsky performance status > 60%

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);

2. Prior stereotactic radiotherapy;

3. Active infection;

4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;

5. Subjects who suffered from an acute cardiac event within the last 12 months;

6. Subjects with active vascular disease, either myocardial or peripheral;

7. Subjects with proliferative and/or vascular retinopathy;

8. Subjects with known active second malignancy;