An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Percent reduction in IGF-1R expression
研究概览
简要总结
This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=18 years of age;
- •invasive, and operable, breast cancer;
- •ECOG Performance Status of 0 or 1.
排除标准
- •evidence of metastatic disease;
- •inflammatory breast cancer;
- •prior hormonal or systemic therapy for breast cancer;
- •prior treatment with an agent targetting the IGF-1R pathway;
- •patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.
研究组 & 干预措施
1
干预措施: RG1507 (Drug)
结局指标
主要结局
Percent reduction in IGF-1R expression
时间窗: From initial diagnosis to tumor excision
次要结局
- Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue(Days 1, 8 and 31)
- Adverse events, laboratory parameters(Throughout study)