Status:
UNKNOWN
GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
Lead Sponsor:
Genexine, Inc.
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Age ≥ 19 years
- Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
- Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
- Life expectancy \> 12 weeks
- Adequate hematologic and end organ function
Exclusion
- Malignancies other than disease under study within 5 years prior to the first dose of study drug
- Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
- Body Mass Index (BMI) ≥ 30 kg/m2
- Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
- Clinically significant cardiovascular disease
- History of arterial or venous thromboembolism 6 months prior to study participation
- Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
- History of hypertensive crisis or hypertensive encephalopathy
- Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
- Pregnancy or breastfeeding.
- Subjects with active virus infection
- Subjects with autoimmune disease/ syndromes
- 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
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05191784
Start Date
January 26 2022
End Date
December 31 2024
Last Update
June 12 2023
Active Locations (1)
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1
Seoul St.Mary's Hospital of the Catholic University of Korea
Seoul, South Korea, 137-701