NCT02467361已完成1 期
A Phase Ib/II Clinical Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors to Adult Patients With Advanced Cancers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
研究概览
简要总结
This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Combo with Ipilimumab
Experimental
干预措施: BBI608 (Drug)
Combo with Ipilimumab
Experimental
干预措施: Ipilimumab (Drug)
Combo with Nivolumab
Experimental
干预措施: BBI608 (Drug)
Combo with Nivolumab
Experimental
干预措施: Nivolumab (Drug)
Combo with Pembrolizumab
Experimental
干预措施: BBI608 (Drug)
Combo with Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)
时间窗: 6 weeks
Determination of the safety and tolerability of BBI608 administered in combination with selected immunotherapeutic agent by assessing dose-limiting toxicities (DLTs)
时间窗: 6 weeks
次要结局
- Pharmacokinetic profile of BBI608 administered in combination with the selected immunotherapeutic agent as assessed by maximum plasma concentration and area under the curve(-5min, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours on day 1, cycles 1 and 2)
- Pharmacodynamic activity of BBI608 administered in combination with the selected immunotherapeutic agent as assessed by biomarker analysis(6 months)
- Assessment of the preliminary anti-tumor activity by performing tumor assessments every 8 weeks (Phase 2 portion)(6 months)
研究者
研究点 (8)
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