A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation
研究概览
简要总结
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
详细描述
This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
- •Unresectable or metastatic disease
- •No available treatment with curative intent
- •Adequate organ function
排除标准
- •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
- •Other active cancer
- •Cardiac abnormalities
研究组 & 干预措施
Dose escalation
Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
干预措施: MRTX849 (Drug)
Dose escalation
Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
干预措施: BI 1701963 (Drug)
Dose expansion
Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963
干预措施: MRTX849 (Drug)
Dose expansion
Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963
干预措施: BI 1701963 (Drug)
结局指标
主要结局
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation
时间窗: 20 months
Number of participants with treatment related adverse events
Establish Maximum Tolerated Dose
时间窗: 12 months
Number of patients with dose limiting toxicity
Evaluate Pharmacokinetics of the combination regimen
时间窗: 20 months
Blood plasma concentration
次要结局
- Evaluate preliminary clinical activity of the combination regimen(20 months)