Study of RMC-6291, With or Without RMC-6236, in Combination With Other Anti-Cancer Agents, in Patients With RAS G12C-Mutated Non-Small Cell Lung Cancer – Subprotocol A
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 40
- 主要终点
- • Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs
研究概览
简要总结
To evaluate the safety and tolerability of RMC6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated solid tumors To define the RP2DS for RMC-6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated NSCLC
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Phase 1b/2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age and signed the Informed Consent Form (ICF)
- •Patients that have solid tumor with RAS-G12C.
- •Patients that have received prior cancer treatment or are not able to tolerate regular treatments.
- •Patients that have at least one tumor lesion (an area of abnormal tissue) that can be measured.
- •Patients that have adequate organ function (bone marrow, liver, kidney).
排除标准
- •Participants that have primary brain and spinal cord tumor.
- •Participants thathave gastrointestinal problems that may affect absorption of RMC-
- •Participants thathad any major surgery in the last 4 weeks.
- •Participants thathave any other medical condition that may interfere with the study drugs.
- •Participants that have previously taken targeted therapy for KRAS mutation.
结局指标
主要结局
• Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs
• Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs
次要结局
- RMC-6291 plasma concentrations overtime and PK parameters as applicable. RMC-6291 plasma and RMC-6236 blood concentration over time and PK parameters as applicable • ORR and DOR per RECIST v1.1
研究者
Melanie Caruno
Scientific
Revolution Medicines Inc.