Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Biological: Recombinant full human Anti-EGFR Monoclonal Antibody
- Registration Number
- NCT02211443
- Lead Sponsor
- Sinocelltech Ltd.
- Brief Summary
The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 21
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aged from 18 to 70 years;
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having histologically confirmed metastatic colorectal cancer;
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having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
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having determined wild-type KRAS tumor;
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having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months;
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adequate hematological, renal and liver functions:
- Hematological function: white blood cell count of >4.0×109/L; absolute neutrophil count of >1.5×109/ L; platelet count of >100×109/L; hemoglobin level of >90.0 g/L;
- Renal function: serum creatinine level of<1.5×upper limit of normal (ULN);
- Liver function: total bilirubin level of<1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of <1.5×ULN; or <5 × ULN for patients with liver metastases;
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no other malignancies only if they had following malignancies , which were not required to treat or who had curative resection: cervical carcinoma in situ, the skin basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they had some malignancies requirement only surgical therapy and disease free survival≥5 years;
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no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder.
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not pregnant; or not lactating; or accepted birth control methods during the study;
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signed an informed consent form which was approved by the institutional review board of the respective medical center .
- had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody;
- having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy;
- chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication);
- had recent major surgery (within 28 days);
- with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment);
- with active infection requirement systemic antibiotics treatment; or serious cardiovascular disease;or with evidence of active hepatitis B or C infection; or with human immunodeficiency virus infection;
- had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic obstructive pulmonary disease (COPD) or with risk factors to COPD;
- with eye inflammation or infection, or any risk factors who could lead to eye disease;
- with a history of allergic reaction or protein product allergy including antibodies product;
- pregnant, or lactating, or not accepted birth control methods including male patients.
- had a history of alcohol or drugs addiction, or with any risk which may affect the patient's health evaluation or mantle state
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Single arm Recombinant full human Anti-EGFR Monoclonal Antibody Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody: First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups.
- Primary Outcome Measures
Name Time Method Number of participants with SCT200-related adverse events up to 105 days
- Secondary Outcome Measures
Name Time Method Area Under the plasma concentration versus time curve (AUC) of SCT200 prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose