Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Stomach Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

GC1118 recombinant human anti-EGFR antibody

For Part A, GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in the dose escalation cohorts, starting 0.3mg/kg until Maximum Tolerated Dose is defined.

For Part B, the defined MTD/RP2D of GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in patients with stage IV of gastric cancer, colorectal cancer or other cancers.

For Part C, GC1118 will be administered by IV infusion once every 2 weeks for 4 weeks (28-day cycles) in patients with all stage IV advanced solid cancers.

Part A, Part B and Part C participants who qualify for subsequent cycles will receive continued GC1118 until evidence of progression of disease.

GC1118

Ahmi Woo

Yung Jue Bang, M.D., Ph.D.

Yung Jue Bang, Ph.D.

The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV solid tumors.

The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers.

An open-label, single-arm, multi-center, phase 1, dose-escalation study will be conducted to define the MTD/RP2D, safety, PK, immunogenicity and antitumor activity of GC1118 in patients with refractory disease for whom no standard therapy is available.

This study is in three parts: a dose escalation segment (Part A), a cohort expansion (Part B) and biweekly administration(Part C). In part A, a dose escalation schema will be applied in dose level cohorts. GC1118 will be administered weekly on Study Day 1, 8, 15, and 22 of each 28-day cycle by IV infusion. Dose escalation may occur as described in the study protocol. Once the MTD has been established during Part A, the MTD cohort will be expanded in part B. And GC1118 will be administered biweekly on Study Day 1, 15 each 28-day cycle by IV infusion in part C.

Study assessments will include AE monitoring including physical examination, vital signs and clinical laboratory tests, ECG monitoring, PK analysis of serum GC1118, an assessment of potential anti-GC1118 antibody response and an exploration of potential prognostic and pharmacodynamic biomarkers.

Tumor response assessments using Study Day 36 CT/MRI scans will be performed approximately five weeks after the first GC1118 dose for each patient (Part A only). Patients with evidence of disease regression (partial or complete response or stable disease by RECIST criteria) will be allowed to continue therapy at the same dose. Subsequent cycles will consist of administration of GC1118 on Day 1, 8, 15, and 22 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part A,B and Day 1, 15 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part C.

Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer

A Prospective, Open-label, Dose Escalation (Part A) and Cohort Expansion (Part B) Phase 1 Study to Investigate the Safety, Tolerability, and Immunogenicity and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancers

Vital sign assessment will include systolic and diastolic blood pressure, heart rate, respiration rate and temperature. Laboratory values will include hematology and clinical chemistry.

Assess whether participants develop an immune response to GC1118

Green Cross Corporation

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Mitogens

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.

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.

sehoon lee, professor

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

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.

GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

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

survival time from screening to progression defined by RANO criteria

survival time from screening to death of any cause

best overall response rate defined by RANO criteria

according to NGS-based biomarkers(whole exome sequencing and whole transcriptome sequencing)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer	NCT02352571	Neoplasm Metast... Gastric Cancer Colorectal Canc...	GC1118	19 Years -	GC Biopharma Corp
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification	NCT03618667	Glioblastoma, A... EGFR Amplificat...	GC1118	19 Years -	Samsung Medical Center
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification	NCT03618667	Glioblastoma, A... EGFR Amplificat...	GC1118	19 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for gc1118

Every month we try and update this database with for gc1118 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gc1118

Every month we try and update this database with for gc1118 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gc1118 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.