NCT00320827已完成1 期
Phase 1 Study of CS-1008, a Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), Administered Weekly to Patients With Advanced Solid Malignancies and Lymphomas (Without Leukemic Component)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To determine the recommended Phase 2 dose
研究概览
简要总结
This is a dose escalation study of CS-1008 (humanized anti-DR5 antibody) to determine the recommended Phase 2 dose and the maximum tolerated dose. Drug will be administered for six weeks and possibly up to 12 weeks depending on response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 or cytologically diagnosed metastatic solid tumors or lymphomas (with no leukemic component) which are refractory to, not curable with, or not eligible for standard treatment(s).
- •Eighteen years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2
- •Resolution of any toxic effects (except alopecia) of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 grade of equal to or less than 1
- •Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
- •All female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to treatment
- •Patients must be fully informed about their illness and the investigational nature of the study protocol
排除标准
- •Anticipation of the need for a major surgical procedure or radiation therapy during the study
- •Treatment with chemotherapy, hormonal therapy, radiotherapy, major surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study enrollment
- •Cumulative radiation therapy to greater than 25% of the total bone marrow
- •Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolytic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma)
- •Patients with a clinically active brain metastasis (i.e., not treated or still requiring therapy with steroids or radiotherapy [RT]; or with progression 4 weeks after the completion of RT) or an uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
- •Clinically significant active infection which requires antibiotic therapy, or HIV-positive patients receiving antiretroviral therapy.
- •Chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction
结局指标
主要结局
To determine the recommended Phase 2 dose
次要结局
- To investigate the pharmacokinetics of CS-1008 administered weekly
- To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies
- To study potential biomarkers of CS-1008 activity
- To make preliminary assessments of anti-tumor effects of CS-1008
研究者
研究点 (2)
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