Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-04 @ 8:08 AM
Study NCT ID:
NCT03356158
Status:
UNKNOWN
Last Update Posted:
2018-09-17
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Study of Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Human-mouse Chimeric Monoclonal Antibody Injection in Patients With Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2017-11
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:
This is an open-label, parallel designed study to assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The immunogenicity and preliminary efficacy of CPGJ602 will also be assessed. The study includes 3 parts: part 1: after a single dose of CPGJ602 or cetuximab (the active comparator), the patients will be observed for 4 weeks; part 2: CPGJ602 or cetuximab will be administered to the patients once a week for 5 weeks; part 3: CPGJ602 will be administered to the patients once a week until the patient's death or the withdrawal decision of the patient and/or investigator.
Detailed Description:
OBJECTIVES:
Primary:
To assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of CPGJ602 administered by intravenous infusion.
Secondary:
To assess the immunogenicity and anti-tumor activity of CPGJ602, compare the pharmacokinetics and immunogenicity between CPGJ602 and the active comparator, cetuximab, and to provide scientific basis for the subsequent phase 2/3 clinical trials.
OUTLINE:
This is an open-label, parallel designed study in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The study can be divided into 3 parts:
Part 1: Single-dose Part
* Arm A: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
* Arm B: CPGJ602, IV over 2 hours, 400 mg/m2 X 1;
* Arm C: Cetuximab, IV over 2 hours, 400 mg/m2 X 1.
Part 2: Multi-dose Part
The subjects from arm A in Part 1 will be randomized into arm B or C.
* Arm B: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;
* Arm C: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. The completion of Day 63 Visit (the visit on the 7th day after the 5th dose in Part 2) can be considered as the completion of the study.
Part 3 (Follow-up Part)
CPGJ602, IV over 1 hour, QW, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.
Primary:
To assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of CPGJ602 administered by intravenous infusion.
Secondary:
To assess the immunogenicity and anti-tumor activity of CPGJ602, compare the pharmacokinetics and immunogenicity between CPGJ602 and the active comparator, cetuximab, and to provide scientific basis for the subsequent phase 2/3 clinical trials.
OUTLINE:
This is an open-label, parallel designed study in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The study can be divided into 3 parts:
Part 1: Single-dose Part
* Arm A: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
* Arm B: CPGJ602, IV over 2 hours, 400 mg/m2 X 1;
* Arm C: Cetuximab, IV over 2 hours, 400 mg/m2 X 1.
Part 2: Multi-dose Part
The subjects from arm A in Part 1 will be randomized into arm B or C.
* Arm B: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;
* Arm C: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time. The completion of Day 63 Visit (the visit on the 7th day after the 5th dose in Part 2) can be considered as the completion of the study.
Part 3 (Follow-up Part)
CPGJ602, IV over 1 hour, QW, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: