Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02352571
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2015-01-21
Brief Title:
Safety Study of GC1118 Recombinant Human Anti-EGFR Antibody in Patients With Advanced Solid Cancer
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the maximum tolerated doseMTDRecommended Phase 2 DoseRP2D 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
The study will also evaluate pharmacokinetics immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers
Detailed Description:
An open-label single-arm multi-center phase 1 dose-escalation study will be conducted to define the MTDRP2D 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 administrationPart 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 CTMRI 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 AB and Day 1 15 of each 28-day cycle with tumor evaluation every other cycle approximately every 8 weeks in part C
This study is in three parts a dose escalation segment Part A a cohort expansion Part B and biweekly administrationPart 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 CTMRI 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 AB and Day 1 15 of each 28-day cycle with tumor evaluation every other cycle approximately every 8 weeks in part C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None