Recurrent Glioblastoma
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGGX-I7
Administered by intramuscular (IM) injection
DRUGBevacizumab
Administered by intravenous (IV) injection
Sponsors
Genexine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 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. | Progression free survival (PFS) by iRANO criteria |
| Overall survival (OS) | From the initiation of study treatment until the date of death from any cause, assessed up to 24 months. | Overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR (Disease control rate) | From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months. | DCR (Disease control rate) by iRANO criteria |
| Incidence of adverse events (AEs) | Through study completion, an average of 1 year | The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0 |
| ORR (Objective response rate) | From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months. | ORR (Objective response rate) by iRANO criteria |
| Immunogenicity (neutralizing antibody) | Day 1 and Day 43 of each cycle (8-week interval) | The incidence rate of anti-drug antibodies (neutralizing antibody) |
| Absolute counts and ratios of immune cell subtypes | Day 1 and Day 29 of each cycle (8-week interval) | Changes of absolute counts and ratios of immune cell subtypes |
| Immunogenicity (ADA) | Day 1 and Day 43 of each cycle (8-week interval) | The incidence rate of anti-drug antibodies (ADAs) |
| DOR (Duration of response) | From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months. | DOR (Duration of response) by iRANO criteria |
Countries
South Korea
Outcome results
None listed