Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 试验地点
- 106
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
详细描述
This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
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
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
- •Subject must be ≥18 years of age.
- •Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
- •ECOG performance status 0 or 1
- •Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and for NSCLC in dose expansion
- •Adequate organ function
排除标准
- •Primary central nervous system (CNS) tumors
- •Active brain metastases
- •Known impairment of GI function that would alter the absorption
- •Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
- •Prior therapy with KRASG12C (ON) inhibitor
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
RMC-6291
Dose Escalation and Dose Expansion
干预措施: RMC-6291 (Drug)
结局指标
主要结局
Adverse events
时间窗: up to 3 years
Number of participants with adverse events
Dose Limiting Toxicities
时间窗: The first 21 days (i.e. Cycle 1)
Number of participants with dose limiting toxicities
次要结局
- Maximum Observed Blood Concentration of RMC-6291(7 Cycles)
- Time to Reach Maximum Blood Concentration of RMC-6291(7 Cycles)
- Area Under Blood Concentration Time Curve of RMC-6291(7 Cycles)
- Elimination Half-Life of RMC-6291(7 Cycles)
- Overall Response Rate (ORR)(3 years)
- Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing(7 Cycles)
- Time to Response (TTR)(3 years)
- Progression-Free Survival (PFS)(3 years)
- Duration of Response (DOR)(3 years)
- Disease Control Rate (DCR)(3 years)