A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Evaluate preliminary clinical activity of the combination regimen
研究概览
简要总结
This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.
详细描述
This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.
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
- •Unresectable or metastatic disease.
- •No available treatment with curative intent
- •Adequate organ function
排除标准
- •History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
- •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
- •Other active cancer
- •Cardiac abnormalities
研究组 & 干预措施
Dose Escalation
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
干预措施: MRTX849 (Drug)
Dose Escalation
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
干预措施: Palbociclib (Drug)
Dose Expansion
Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
干预措施: MRTX849 (Drug)
Dose Expansion
Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
干预措施: Palbociclib (Drug)
结局指标
主要结局
Evaluate preliminary clinical activity of the combination regimen
时间窗: 24 months
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
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: 24 months
Number of participants with treatment emergent adverse events
Evaluate Pharmacokinetics of the combination regimen
时间窗: 24 months
Plasma concentration
Establish Maximum Tolerated Dose
时间窗: 24 months
Number of patients with dose limiting toxicity
次要结局
未报告次要终点