Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
研究概览
简要总结
This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients aged 2-17 years of age;
- •histologically confirmed solid tumors;
- •cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.
排除标准
- •treatment with corticosteroids within past 2 weeks;
- •current or past use of anti-IGF-1R antibodies;
- •current treatment with immunosuppressive agents;
- •patients with diabetes mellitus;
- •known HIV or hepatitis B or C;
- •hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
研究组 & 干预措施
1
干预措施: RG1507 (Drug)
2
干预措施: RG1507 (Drug)
3
干预措施: RG1507 (Drug)
结局指标
主要结局
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
时间窗: Throughout study
次要结局
- MTD (AEs, laboratory parameters)(Throughout study)