A Phase 1 Dose Escalation Study of Combination Therapy With Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Identification of maximum tolerated dose
研究概览
简要总结
Primary Objective:
- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors.
Secondary Objective:
- To characterize the safety and tolerability of SAR245408 and MSC1936369B combination therapy administered orally to adult patients with locally advanced or metastatic solid tumors
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in combination
- To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by assessing target and pathway inhibition
详细描述
The duration of the study will include a period for screening of up to a maximum of 28 days, a pretreatment evaluation period of up to 5 days, the on-treatment period, followed by a minimum of 30-day follow-up after the last study drug administration.
The patient may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal.
The study will have 2 parts:
- Part one - Dose Escalation
- Part Two - Expansion. At the defined maximum tolerated doses (MTD(s), additional patients will be enrolled to collect safety, Pharmacokinetic, and Pharmacodynamic data
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation
Dose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg)
干预措施: SAR245408 (XL147) (Drug)
Dose Escalation
Dose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg)
干预措施: MSC1936369B (Drug)
结局指标
主要结局
Identification of maximum tolerated dose
时间窗: up to 4 years
次要结局
- Number of participants with treatment emergent adverse events(up to 4 years)
- Pharmakokinetic parameters of MSC1936369B: AUCι(up to 4 years)
- Pharmakokinetic parameters of SAR245408: Cmax(up to 4 years)
- Pharmakokinetic parameters of SAR245408: Tmax(up to 4 years)
- Pharmakokinetic parameters of SAR245408:AUCι(up to 4 years)
- Pharmakokinetic parameters of MSC1936369B: Cmax(up to 4 years)
- Pharmakokinetic parameters of MSC1936369B: Tmax(up to 4 years)