A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.
Secondary Objectives:
- To characterize the global safety profile of SAR245408 in combination with SAR256212
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
- To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
- To determine the immunogenicity of SAR256212 as administered with SAR245408
详细描述
There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dose escalation and expansion
SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose
干预措施: MM-121 (SAR256212) (Drug)
dose escalation and expansion
SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose
干预措施: SAR245408 (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: 2 months to 12 months
次要结局
- overall response rate(2 months to 2 years)
- Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured(1 month to 6 months)
- Number of patients who develop anti-MM-121 antibodies(1 month to 6 months)
- Peak and trough levels of SAR256212 and SAR245408(1 month to 6 months)
- Number of participants with adverse events(1 month to 2 years)