GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Study Overview
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Brief Summary
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This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

Detailed Description
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This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation. GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Official Title
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A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification

Conditions
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Glioblastoma, Adult, EGFR Amplification

Intervention / Treatment
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* Drug: GC1118


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent 19 years or older patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide) high EGFR amplification available archive tumor sample(s) Karnofsky performance status (KPS) > 70 life expectancy > 3 months adequate end-organ function patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1) Exclusion Criteria: patients who had EGFR target agent(s) before screening patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease) patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks patients who had investigation drug(s) within previous 4 weeks patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer) patients who had severe infection within previous 4 weeks HIV infection patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc) pregnancy or breast-feeding

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: single group<br>GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles, or till progression or uncontrolled toxicity. | Drug: GC1118<br>* GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | survival time from screening to progression defined by RANO criteria | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | survival time from screening to death of any cause | 6 months, 12 month | 
| overall response rate | best overall response rate defined by RANO criteria | up to 30months | 
| Exploration of predictive/prognostic biomarkers | according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing) | up to 30 months |