Clinical trial · Interventional
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
NCT03618667CI-TRIAL-00066388completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Amplification | — | UNRESOLVED | — |
| Glioblastoma, Adult | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GC1118 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single 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.
- interventionNames
- Drug: GC1118
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- at 6 months
- description
- survival time from screening to progression defined by RANO criteria
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 6 months, 12 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.