NCT02211443Unknown1 期
A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 21
- 主要终点
- Number of participants with SCT200-related adverse events
研究概览
简要总结
The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 18 to 70 years;
- •having histologically confirmed metastatic colorectal cancer;
- •having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
- •having determined wild-type KRAS tumor;
- •having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months;
- •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;
- •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;
- •no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder.
- •not pregnant; or not lactating; or accepted birth control methods during the study;
- •signed an informed consent form which was approved by the institutional review board of the respective medical center .
排除标准
- •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
结局指标
主要结局
Number of participants with SCT200-related adverse events
时间窗: up to 105 days
次要结局
- 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)
研究者
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