NCT03405272Unknown2 期
Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Chemotherapy- Refractory Wild Type RAS and BRAF Metastatic Colorectal Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 21
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR Monoclonal antibody（SCT200）in patients with wild-type RAS and BRAF mCRC treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Single Arm, Open-label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent and can understand and comply with the requirements of the study;
- •Men and women ≥ 18 years of age;
- •Life expectancy of longer than 3 months ( clinical assessment);
- •With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- •Have been diagnosed as mCRC verified histologically;
- •Patients treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy. Disease progressed or developed non-tolerable toxicity after systemic chemotherapy：a. at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy ; b. May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented;
- •RAS and BRAF wildtype status of primary colorectal cancer or related metastasis;
- •Adequate organ and marrow function as defined below:
- •Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN); Serum creatinine less than/equal to 1.5 times IULN; Electrolyte: magnesium greater than/equal to normal.
- •According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI. Longest diameter greater than/equal to10mm（CT scan slice thickness no greater than 5 mm）, a lymph node must be ≥15mm in short axis when assessed by CT scan.
排除标准
- •Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis, untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 28 days;
- •Patients with other primary malignancies within the past 5 years except non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia;
- •Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
- •Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
- •Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
- •Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
- •Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
- •Patients treated with EPO, G-CSF or GM-CSF.
- •Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);
- •Patients occurred myocardial infarction within 6 months.
- •Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
- •Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
- •Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
- •Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
- •Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
- •Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
- •Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
- •Patients have alcohol or drug addiction;
- •Inability to comply with study and/or follow-up procedures
研究组 & 干预措施
recombinant anti-EGFR monoclonal antibody（SCT200）
Experimental
Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
干预措施: Recombinant Anti-EGFR Monoclonal Antibody（SCT200） (Biological)
结局指标
主要结局
Objective response rate
时间窗: 1 year
The achievement of either a partial response (PR) or complete response (CR), according to RECIST 1.1 criteria
次要结局
- Objective response rate - left side(1 year)
- Best of response(1 year)
- Disease control rate(1 year)
- Time to response(1 year)
- Progression free survival(1 year)
- Duration of response(1 year)
- Overall survival(1 year)
研究者
研究点 (21)
Loading locations...
相似试验
Unknown
1 期
Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung CancerAdvanced Squamous Non-small Cell Lung CancerNCT03808701Sinocelltech Ltd.50
Unknown
2 期
Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast CancerTriple Negative Breast NeoplasmsNCT03692689Sinocelltech Ltd.30
Unknown
1 期
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT03692520Sinocelltech Ltd.90
Unknown
1 期
Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT03817567Sinocelltech Ltd.50
Unknown
2 期
Safety and Efficacy of SCT200 in Head and Neck Squamous Cell CarcinomaHead and Neck CancerNCT03713372Sinocelltech Ltd.40