Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Number of Participants with Dose Limiting Toxicity (DLT)
研究概览
简要总结
The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.
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
- •Participants must have received a PD-1 PDLI therapy within 9 weeks of starting dosing on this study [for example, nivolumab, pembrolizumab, atezolizumab]
- •Participants must be willing to have tumor biopsies
- •Participants must have adequate organ function
- •Participants must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- •Participants must be able to swallow tablets
- •Participants with stable, previously treated brain metastases may participate if neurologic symptoms have resolved and participants have been off steroids for at least 14 days
排除标准
- •Participants must not have moderate or severe cardiovascular disease
- •Participants must not have active autoimmune disease (for example Crohn's disease, Hashimotos disease, etc)
- •Participants must not have an active infection requiring treatment
研究组 & 干预措施
LY3200882 and Pembrolizumab (Dose Level 1)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
干预措施: LY3200882 (Drug)
LY3200882 and Pembrolizumab (Dose Level 1)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).
干预措施: Pembrolizumab (Drug)
LY3200882 and Pembrolizumab (Dose Level 2)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
干预措施: LY3200882 (Drug)
LY3200882 and Pembrolizumab (Dose Level 2)
Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.
干预措施: Pembrolizumab (Drug)
LY3200882 and Pembrolizumab Expansion
Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.
干预措施: LY3200882 (Drug)
LY3200882 and Pembrolizumab Expansion
Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: Up to 6 Weeks
Number of Participants with DLT
次要结局
- Duration of Response (DoR)(Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months))
- Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)(Baseline through Disease Progression or Death (Estimated at up to 12 Months))
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab(Baseline through Week 13)