NCT00688415已完成1 期
A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Safety and identification of dose-limiting toxicities
研究概览
简要总结
This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.
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
- Other
- 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
- •Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility.
- •Inclusion Criteria:
- •Ability and willingness to provide written informed consent
- •Histologically or cytologically confirmed solid tumors or lymphoma
- •Locally advanced or metastatic disease
- •Life expectancy of at least 16 weeks
- •ECOG performance status of 0 or 1
- •Acceptable physical exam and laboratory tests at study entry
- •Willingness to use medically acceptable contraception
- •A negative serum pregnancy test for women with reproductive potential
排除标准
- •Anticancer therapy within 2 weeks
- •Treatment with an investigational agent within 4 weeks
- •Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
- •Known brain metastases unless stable for at least 28 days
- •Active autoimmune disease
- •Insulin-dependent diabetes mellitus
- •Clinically significant cardiac disease within 6 months
- •Significant infection or fever within 1 week
- •Pregnant or breast-feeding females
- •Other conditions or circumstances that could interfere with the study
结局指标
主要结局
Safety and identification of dose-limiting toxicities
时间窗: Study duration
Pharmacokinetics
时间窗: First dose of investigational drug
次要结局
- Pharmacodynamics(Study duration)
- Identification of the MTD(First cycle of investigational drug)
研究者
研究点 (2)
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