GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Phase 2

Completed

• Conditions: Glioblastoma, Adult; EGFR Amplification
• Interventions: Drug: GC1118

• Registration Number: NCT03618667
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-08-05
• Study First Posted: 2018-08-07
• Primary Completion: 2018-09-08
• Study Completion: 2022-04-28
• Status Verified: 2022-11
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group	GC1118	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	at 6 months	survival time from screening to progression defined by RANO criteria

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of