GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

NCT03618667 | Completed Phase 2

• 1 other identifier: SMC2017-06-111
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma, Adult; EGFR Amplification

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  survival time from screening to progression defined by RANO criteria

  at 6 months

Secondary Outcomes (3)

• overall survival

  6 months, 12 month

• overall response rate

  up to 30months

• Exploration of predictive/prognostic biomarkers

  up to 30 months

Study Arms (1)

single group

EXPERIMENTAL

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.

Drug: GC1118

Interventions

GC1118 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.

single group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• years or older
• patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
• high EGFR amplification
• available archive tumor sample(s)
• Karnofsky performance status (KPS) \> 70
• life expectancy \> 3 months
• adequate end-organ function
• patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)

You may not qualify if:

• patients who had EGFR target agent(s) before screening
• 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)
• patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
• patients who had investigation drug(s) within previous 4 weeks
• 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)
• patients who had severe infection within previous 4 weeks
• HIV infection
• patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
• clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
• pregnancy or breast-feeding

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

GC1118

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• sehoon lee, professor

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: August 7, 2018
• Study Start: January 22, 2018
• Primary Completion: September 8, 2018
• Study Completion: April 28, 2022
• Last Updated: May 12, 2023

Record last verified: 2022-11

Locations

KR (1)