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

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Genexine, Inc.
Updated on 4 October 2022


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.

Condition Recurrent Glioblastoma
Treatment bevacizumab, GX-I7
Clinical Study IdentifierNCT05191784
SponsorGenexine, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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