GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

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.

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