GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03618667

Enrollment

Registered

2018-08-07

Start date

2018-01-22

Completion date

2022-04-28

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Amplification, Glioblastoma, Adult

Brief 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.

Detailed 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.

Interventions

DRUGGC1118

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026