A Phase 1b/2 Open-Label, Multicenter Study of RMC-9805 with or without RMC-6236, in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 45
- 主要终点
- 1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only).
研究概览
简要总结
To evaluate the safety and tolerability of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated solid tumors. To determine the RP2DS of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated NSCLC.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients that are at least 18 years of age
- •Patients that have NSCLC with RAS-G12D mutation.
- •Patients that have had cancer treatment before or are not able to tolerate regular treatments.
- •Patients that have at least 1 measurable tumor (lesion).
- •Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.
排除标准
- •Patients that have primary brain and spinal cord tumor.
- •Patients that have gastrointestinal problems that may affect absorption of the study drug medicine
- •Patients that had any major surgery in the last 4 weeks.
- •Patients that have any other medical condition that may interfere with the study medicine.
- •Patients that have previously taken targeted therapy for KRAS mutation.
结局指标
主要结局
1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only).
1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only).
2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.
2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.
次要结局
- 1. Concentrations of RMC-9805 and RMC-6236 (if applicable) in blood over time.
- 2. ORR and DOR as per RECIST v1.1
研究者
Melanie Caruno
Scientific
Revolution Medicines Inc.