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