Last updated: June 8, 2023
Sponsor: Genexine, Inc.
Overall Status: Active - Not Recruiting
Phase
2
Condition
Gliomas
Astrocytoma
Treatment
Bevacizumab
GX-I7
Clinical Study ID
NCT05191784
GX-I7-CA-010
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 19 years
- Histologically diagnosed glioblastoma patients who have been confirmed the progressionof 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
Exclusion Criteria:
- Malignancies other than disease under study within 5 years prior to the first dose ofstudy drug
- Subjects who have received bevacizumab or other VEGF inhibitors prior to studyparticipation
- 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 appropriateantihypertensive therapy)
- History of hypertensive crisis or hypertensive encephalopathy
- Subjects receiving therapeutic anticoagulation (except low molecular weight heparin orwarfarin)
- 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 oranticipation that such a live attenuated vaccine will be required during the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions tochimeric or humanized antibodies or fusion proteins
- Severe infections during the screening period, including but not limited tocomplications of infection, bacteremia or severe pneumonia
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Bevacizumab
Phase: 2
Study Start date:
January 26, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Seoul St.Mary's Hospital of the Catholic University of Korea
Seoul, 137-701
Korea, Republic ofSite Not Available

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