GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

Glioblastoma, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618667
• Other study ID #: SMC2017-06-111
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2018
• Est. completion date: April 28, 2022

Study information

• Verified date: November 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 28, 2022
• Est. primary completion date: September 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• EGFR Amplification
• Glioblastoma
• Glioblastoma, Adult

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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