Back to resultsA Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CPGJ602
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer,, Recombinant Anti-EGFR Monoclonal Antibody
Eligibility Criteria
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.
Sites / Locations
- Sir Run Run Shaw HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CPGJ 602 low dose
CPGJ 602 normal dose
Cetuximab normal dose
Arm Description
Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
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;
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.
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration [Cmax]
part 1 for single dose and part 2 for multiple doses
Half life of CPGJ602 in blood [t1/2]
part 1 for single dose and part 2 for multiple doses
Area Under the Curve [AUC]
part 1 for single dose and part 2 for multiple doses
Incidence of Adverse Events [AEs]
to evaluate the safety and tolerability
Secondary Outcome Measures
Anti-Drug Antibody [ADA]
to evaluate the Immunogenicity; if the result is positive, Neutralizing Antibody [NAB] will also be assessed.
Objective Response Rate [ORR]
the rate of completely response [CR] and partial response [PR] patients
Carcinoembryonic antigen [CEA]
Tumor Marker
Cancer antigen [CA19-9]
Tumor Marker
Full Information
NCT ID
NCT03356158
First Posted
November 9, 2017
Last Updated
September 13, 2018
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03356158
Brief Title
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer,, Recombinant Anti-EGFR Monoclonal Antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPGJ 602 low dose
Arm Type
Experimental
Arm Description
Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;
Arm Title
CPGJ 602 normal dose
Arm Type
Experimental
Arm Description
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;
Arm Title
Cetuximab normal dose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CPGJ602
Intervention Description
Injection, q.w., 20 mg: 100 ml
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Intervention Description
Injection, q.w., 20 mg: 100 ml
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration [Cmax]
Description
part 1 for single dose and part 2 for multiple doses
Time Frame
Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Title
Half life of CPGJ602 in blood [t1/2]
Description
part 1 for single dose and part 2 for multiple doses
Time Frame
Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Title
Area Under the Curve [AUC]
Description
part 1 for single dose and part 2 for multiple doses
Time Frame
Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses
Title
Incidence of Adverse Events [AEs]
Description
to evaluate the safety and tolerability
Time Frame
Day -28 to 1 month following the last administration
Secondary Outcome Measure Information:
Title
Anti-Drug Antibody [ADA]
Description
to evaluate the Immunogenicity; if the result is positive, Neutralizing Antibody [NAB] will also be assessed.
Time Frame
Day 0 to Day 63, and in the follow-up period.
Title
Objective Response Rate [ORR]
Description
the rate of completely response [CR] and partial response [PR] patients
Time Frame
Day -28 - Day 63
Title
Carcinoembryonic antigen [CEA]
Description
Tumor Marker
Time Frame
Day -28 - Day 63
Title
Cancer antigen [CA19-9]
Description
Tumor Marker
Time Frame
Day -28 - Day 63
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanrui Wu, Master
Phone
13601126093
Email
wuquanrui@3sbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, Doctor
Organizational Affiliation
the Afflicated Hospital of Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, Doctor
Phone
0571-86006922
Email
shonco@sina.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
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