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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion 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 or ECOG status 0-2. 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05191784
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Genexine, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Minkyu Heo
Principal Investigator Affiliation	Genexine, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: GX-I7 and bevacizumab

Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.

Interventions

Drug: - GX-I7

Administered by intramuscular (IM) injection

Drug: - Bevacizumab

Administered by intravenous (IV) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul, Korea, Republic of

Status

Address

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

Seoul, , 137-701

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