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

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

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 19 years
  2. Histologically diagnosed glioblastoma patients who have been confirmed the progressionof 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

Exclusion Criteria:

  1. Malignancies other than disease under study within 5 years prior to the first dose ofstudy drug
  2. Subjects who have received bevacizumab or other VEGF inhibitors prior to studyparticipation
  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 appropriateantihypertensive therapy)
  8. History of hypertensive crisis or hypertensive encephalopathy
  9. Subjects receiving therapeutic anticoagulation (except low molecular weight heparin orwarfarin)
  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 oranticipation that such a live attenuated vaccine will be required during the study
  14. History of severe allergic, anaphylactic, or other hypersensitivity reactions tochimeric or humanized antibodies or fusion proteins
  15. Severe infections during the screening period, including but not limited tocomplications of infection, bacteremia or severe pneumonia
  16. 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

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.

Connect with a study center

  • Seoul St.Mary's Hospital of the Catholic University of Korea

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

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