Status:
UNKNOWN
A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 pat...
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 immunogenic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03356158
Start Date
November 15 2017
End Date
November 30 2018
Last Update
September 17 2018
Active Locations (1)
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1
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310020