GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: EGFR Amplification; Glioblastoma, Adult

Treatments: Drug: GC1118

Study type: Interventional

Funder types: Other

Identifiers

NCT03618667

SMC2017-06-111

Details and patient eligibility

About

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

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. written informed consent
2. 19 years or older
3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
4. high EGFR amplification
5. available archive tumor sample(s)
6. Karnofsky performance status (KPS) > 70
7. life expectancy > 3 months
8. adequate end-organ function
9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)

Exclusion criteria

1. patients who had EGFR target agent(s) before screening
2. 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)
3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
4. patients who had investigation drug(s) within previous 4 weeks
5. 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)
6. patients who had severe infection within previous 4 weeks
7. HIV infection
8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
10. pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

single group

Experimental group

Description:

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.

Treatment:

Drug: GC1118