GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.

A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.

Inclusion Criteria:

1. Age ≥ 19 years
2. Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
3. Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
4. Life expectancy > 12 weeks
5. Adequate hematologic and end organ function

Exclusion Criteria:

1. Malignancies other than disease under study within 5 years prior to the first dose of study drug
2. Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
3. Body Mass Index (BMI) ≥ 30 kg/m2
4. Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
5. Clinically significant cardiovascular disease
6. History of arterial or venous thromboembolism 6 months prior to study participation
7. Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
8. History of hypertensive crisis or hypertensive encephalopathy
9. Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
10. Pregnancy or breastfeeding.
11. Subjects with active virus infection
12. Subjects with autoimmune disease/ syndromes
13. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
14. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
15. Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
16. Prior allogeneic bone marrow transplantation or prior solid organ transplantation