Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
研究概览
简要总结
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR566658
Secondary Objectives:
- To characterize the safety profile of SAR566658
- To evaluate the pharmacokinetic profile of SAR566658
- To assess the potential immunogenicity of SAR566658
- To assess preliminary antitumor activity
- To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
- To assess safety in the alternative schedules of SAR566658 administration
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, a 3-week treatment cycle(s) and a 2-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. 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 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
- Na
- 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
SAR566658
SAR566658 will be administered by intravenous (IV) infusion according to three different schedules
干预措施: SAR566658 (Drug)
结局指标
主要结局
Dose Escalation to determine the maximum tolerated dose (MTD) of SAR566658
时间窗: 3 weeks
Extension Cohorts to evaluate the preliminary anti-tumoral effect of SAR566658
时间窗: Anticancer activity is assessed every 6 weeks
To assess the effect of SAR566658 at the recommended dose on CYP3A enzyme activity using midazolam as probe
时间窗: At D1 and D4 of administration of SAR566658 for 24h of midazolam dosing
次要结局
- Overall safety profile based on adverse events reporting, laboratory tests, vital signs and specific pulmonary and ocular tests, according to the NCI-CTC AE v4.03(Up to 2 years)
- Pharmacokinetic (PK) parameters(Up to 2 years)
- Immunogenicity evaluation (anti-drug antibodies)(Up to 2 years)
- To assess safety in the alternative schedules of SAR566658 administration(Up to 2 years)
- Antitumoral response(Up to treatment discontinuation)
- To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam(Up to Cycle 2)