NCT00801177已完成1 期
Phase I Study of the Fully Human Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody IMC-11F8 in Patients With Solid Tumors Who Have Failed Standard Therapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to determine if IMC-11F8 is safe for patients, and also to determine the best dose of IMC-11F8 to give to patients.
详细描述
The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the fully human anti-EGFR monoclonal antibody IMC-11F8 in patients with solid tumors who have filed standard therapy or for whom no standard therapy is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Histologically-confirmed, EGFR-detectable or EGFR-undetectable, unidimensionally-measurable and/or evaluable solid tumors who failed standard therapy or for whom no standard therapy is available. Patients who do not have tissue available for EGFR testing will undergo a biopsy of an accessible tumor.
- •ECOG performance status score of ≤ 2 at study entry.
- •Able to provide written informed consent.
- •White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L; a hemoglobin level > 90 g/L; and a platelet count ≥ 100 x 109/L.
- •Adequate hepatic function as defined by:
- •an alkaline phosphatase level ≤ 5.0 x the ULN
- •a bilirubin level ≤ 1.5 x the ULN
- •aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases
- •Adequate renal function as defined by a serum creatinine level within normal limits.
- •Use of effective contraception if procreative potential exists.
- •Life expectancy of approximately 3 months in the opinion the opinion of the investigator.
排除标准
- •Chemotherapy, radiation, and/or hormonal therapy (except palliative radiation therapy for disease-related pain and chronic hormonal therapy for prostate carcinoma) within 4 weeks of study entry.
- •Concurrent unstable or uncontrolled medical disease (e.g., active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which, in the opinion of the investigator, could compromise the patient or the study.
- •Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anticonvulsants are allowed).
- •Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the trial.
- •Any condition that prevents the patient from providing informed consent.
- •Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
- •Any investigational agent(s) or device(s) within 4 weeks of study entry.
- •Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted ≥ 4 weeks prior to study entry.
- •Any prior therapy that targeted the EGFR or EGFR pathway.
- •Known history of human immunodeficiency virus.
- •Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.
研究组 & 干预措施
IMC-11F8 (Every week)
Experimental
Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.
干预措施: IMC-11F8 I.V. (Biological)
IMC-11F8 (Every other week)
Experimental
Cycle of therapy administered intravenously, every other week for 6 weeks, for a total of three doses per cycle.
干预措施: IMC-11F8 (Biological)
IMC-11F8 (Every week)
Experimental
Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.
干预措施: IMC-11F8 (Biological)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Approximately 24 Months
Maximum Tolerated Dose of IMC-11F8
时间窗: Approximately 24 Months
次要结局
- Area under the Time Concentration Curve (AUC)(Approximately 24 Months)
- Maximum concentration (Cmax)(Approximately 24 Months)
- Half-life (t 1/2)(Approximately 24 Months)
- Serum Anti-IMC-11F8 Antibody Assessment(Approximately 24 Months)
- Change from baseline in Antitumor Activity(Approximately 24 Months)
研究者
研究点 (2)
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