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GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03618667
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Samsung Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 sehoon lee, professor
Principal Investigator Affiliation Samsung Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Adult, EGFR Amplification
Additional Details

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.

Arms & Interventions

Arms

Experimental: single group

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.

Interventions

Drug: - GC1118

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Samsung Medical Center, Seoul, Korea, Republic of

Status

Address

Samsung Medical Center

Seoul, , 135710

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