Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844
研究概览
简要总结
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD.
To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene amplification.
Secondary Objectives:
To characterize the global safety profile including cumulative toxicities. To evaluate the pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).
To assess preliminary antitumor activity in patients with measurable/evaluable disease, according to RECIST 1.1 criteria.
To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study, in the escalation part only.
To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit from SAR125844.
To explore MET-gene amplification status in circulating DNA.
详细描述
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks and a 4-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. The study will also include 2 expansion cohorts. If a patient treated in dose escalation part or in an expansion cohorts, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment for a maximum of 1 year and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration.
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 SAR125844 will be 50 mg/m^2 up to 960 mg/m^2
干预措施: SAR125844 (Drug)
结局指标
主要结局
Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844
时间窗: At day 28 of Cycle 1 of each treated patient, DLT is assessed
Expansion Cohorts To evaluate the preliminary anti-tumoral effect of SAR125844
时间窗: Anticancer activity is assessed at Day 28 and then every 8 weeks thereafter up to an expected maximum of 2 years
次要结局
- Assessment of PD parameter HGF(Up to 2 years)
- Assessment of PK parameter CL(Up to 2 years)
- Assessment of PK parameter Cmax(Up to 2 years)
- Assessment of PD parameter ShedMET(Up to 2 years)
- Assessment of PK parameter AUCs(Up to 2 years)
- Number of patients with treatment emergent events(Up to 2 years)