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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Drug: GX-I7
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-I7 and bevacizumab<br>Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly. | Drug: GX-I7<br>* Administered by intramuscular (IM) injection<br>* Other names: Efineptakin alfa;Drug: Bevacizumab<br>* Administered by intravenous (IV) injection<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Progression free survival (PFS) by iRANO criteria | 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. | 
| Overall survival (OS) | Overall survival (OS) | From the initiation of study treatment until the date of death from any cause, assessed up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective response rate) | ORR (Objective response rate) by iRANO criteria | 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) | DOR (Duration of response) by iRANO criteria | From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months. | 
| DCR (Disease control rate) | DCR (Disease control rate) by iRANO criteria | From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months. | 
| Incidence of adverse events (AEs) | The incidence rate of adverse events (AEs) graded according to NCI CTCAE v5.0 | Through study completion, an average of 1 year | 
| Immunogenicity (ADA) | The incidence rate of anti-drug antibodies (ADAs) | Day 1 and Day 43 of each cycle (8-week interval) | 
| Immunogenicity (neutralizing antibody) | The incidence rate of anti-drug antibodies (neutralizing antibody) | Day 1 and Day 43 of each cycle (8-week interval) | 
| Absolute counts and ratios of immune cell subtypes | Changes of absolute counts and ratios of immune cell subtypes | Day 1 and Day 29 of each cycle (8-week interval) |