Clinical trial · Interventional
GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
NCT05191784CI-TRIAL-00067094unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| GX-I7 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GX-I7 and bevacizumab
- description
- Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.
- interventionNames
- Drug: GX-I7
- Drug: Bevacizumab
Primary outcomes (2)
- measure
- Progression free survival (PFS)
- timeFrame
- From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
- description
- Progression free survival (PFS) by iRANO criteria
- measure
- Overall survival (OS)
- timeFrame
- From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.