A Phase 1 Study of rSIFN-co for Subjects With Advanced Solid Tumors Where Interferons Are Known to Have Demonstrated Antitumor Activity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will not be enrolled until all subjects at the current dose level complete 28 days without DLT. The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be conducted for all tested dose levels to characterize dose proportionality.
详细描述
The initial cohort will be 3 subjects. Escalation to the next dose will continue unless a subject experiences a DLT, at which time a cohort will be expanded to up to 6 subjects. Provided there is only one DLT in that cohort, the dose will be escalated. However, if there are 2 DLTs in that cohort of up to 6 subjects, previous dose level will be expanded to total of 9 subjects.
If none of the dose levels are acceptable at study completion (i.e., >33% of subjects experiencing a DLT), an OD will not be identified, and the drug does not warrant further investigation.
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
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
sSIFN-co
Dose escalation of rSIFN-co
干预措施: rSIFN-co (Biological)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 28-days
次要结局
未报告次要终点