GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

NCT ID: NCT03618667

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2022-04-28

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.

Conditions

Glioblastoma, Adult; EGFR Amplification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GC1118

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Se-Hoon Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sehoon lee, professor

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SMC2017-06-111

Identifier Type: -

Identifier Source: org_study_id