- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356158
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
A Phase 1 Study of Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Human-mouse Chimeric Monoclonal Antibody Injection in Patients With Metastatic Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310020
- Recruiting
- Sir Run Run Shaw Hospital
-
Contact:
- Hongming Pan, Doctor
- Phone Number: 0571-86006922
- Email: shonco@sina.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-70 years old, male or female.
- Histologically or cytologically confirmed metastatic CRC, and have failed (disease progression or intolerance) at least one prior chemical regimen containing oxaliplatin, irinotecan or 5-FU, etc.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
- RAS (including K-ras and N-ras) wide type status.
Adequate bone marrow, hepatic and renal functions. Hematopoietic:
Leukocytes (WBC)>4.0×109/L or Absolute Neutrophil Count (ANC)> 1.5×109/L, Platelet Count (PLT)>80×109/L, Hemoglobin (Hb)>90g/ L; Hepatic: Total Bilirubin (T-Bil)≤1.5×ULT (Upper Limit of Normal), Alanine Transaminase (ALT)/ Aspartate Transaminase (AST)≤2.5×ULT or ≤5×ULT in case of liver metastases; Renal: Blood Urea Nitrogen (BUN)≤1.5×ULT, Serum Creatinine (Cr) ≤ 1.5×ULT.
- At least one measurable disease based on RECIST criteria (v 1.1).
- Signed informed consent on a voluntary basis at screening, and no geographical condition that would preclude the study compliance.
Exclusion Criteria:
- Less than 28 days since prior chemotherapy, radiotherapy or surgery (diagnosis biopsy is allowed).
- Previous epidermal growth factor receptor (EGFR) targeted therapies (including monoclonal antibody, tyrosine kinase inhibitor [TKI] and other EGFR targeted therapies, such as cetuximab, nimotuzumab, panitumumab, gefitinib, erlotinib, and icotinib, etc.
- Known hypersensitivity to study drugs or any of the excipients.
- Known or clinical suspected brain metastases and/or disease of meninges.
- Clinically significant cardiovascular or cerebrovascular dis ease, history of myocardial infarction (MI) in the latest 6 months, or high-risk of uncontrolled cardiac arrhythmias.
- History of acute or sub-acute intestinal obstruction, or of inflammatory bowel disease.
- A serious and uncontrolled concomitant disease which, in the investigator's opinion, rules out the patient's participation in the study, such as history of malignancies other than CRC (with the exception of: curatively treated carcinoma of the skin [except for melanoma]; cured cervical cancer or basal cell skin cancer, ductal carcinoma in situ [DICS], endometrial carcinoma [stage I grade 1]; and other solid tumors including lymphoma without bone marrow infiltration for which the patient has been disease-free for 5 years), uncontrolled hypertension, diabetes mellitus (DM), peripheral neuropathy, and infectious diseases (including viral, bacterial and parasitic infections), etc.
- Pregnancy or lactation, or a fertility plan during the participation in this study.
- No more than 4 weeks or no more than 5 times of t1/2 since prior investigational agents.
- Other situations that impede the patient's participation in the study at the discretion of the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPGJ 602 low dose
Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
|
Injection, q.w., 20 mg: 100 ml
|
Experimental: CPGJ 602 normal dose
Part 1: CPGJ602, IV over 2 hours, 400 mg/m2 X 1; Part 2: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;
|
Injection, q.w., 20 mg: 100 ml
|
Active Comparator: Cetuximab normal dose
Part 1: Cetuximab, IV over 2 hours, 400 mg/m2 X 1. Part 2: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time.
|
Injection, q.w., 20 mg: 100 ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration [Cmax]
Time Frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
|
part 1 for single dose and part 2 for multiple doses
|
Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
|
Half life of CPGJ602 in blood [t1/2]
Time Frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
|
part 1 for single dose and part 2 for multiple doses
|
Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
|
Area Under the Curve [AUC]
Time Frame: Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
|
part 1 for single dose and part 2 for multiple doses
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Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
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Incidence of Adverse Events [AEs]
Time Frame: Day -28 to 1 month following the last administration
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to evaluate the safety and tolerability
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Day -28 to 1 month following the last administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Drug Antibody [ADA]
Time Frame: Day 0 to Day 63, and in the follow-up period.
|
to evaluate the Immunogenicity; if the result is positive, Neutralizing Antibody [NAB] will also be assessed.
|
Day 0 to Day 63, and in the follow-up period.
|
Objective Response Rate [ORR]
Time Frame: Day -28 - Day 63
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the rate of completely response [CR] and partial response [PR] patients
|
Day -28 - Day 63
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Carcinoembryonic antigen [CEA]
Time Frame: Day -28 - Day 63
|
Tumor Marker
|
Day -28 - Day 63
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Cancer antigen [CA19-9]
Time Frame: Day -28 - Day 63
|
Tumor Marker
|
Day -28 - Day 63
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jianming Xu, Doctor, the Afflicated Hospital of Academy of Military Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPGJ602-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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