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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Genexine, Inc.
• Treatments: Bevacizumab

Criteria

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

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