Overview

GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Status:
Recruiting
Trial end date:
2021-07-31
Target enrollment:
0
Participant gender:
All
Summary
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Criteria
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