CTIS2024-511793-71-00招募中1 期
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1) - NVL-520
uvalent Inc.0 个研究点目标入组 249 人开始时间: 2024年3月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 249
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •1. Age =18 years a. Phase 2 Cohort 2e only: Age =12 years and weighing > 40 kg. 2. Disease criteria a. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. b. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic ROS1 rearrangement. c. Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2d) with ROS1 rearrangement. 3. Prior anticancer treatment 4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease, defined as =1 radiologically measurable target lesion according to RECIST 1.1. 5. Pre-treatment tumor tissue. Please refer to the protocol for further criteria.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study: 1. Patient’s cancer has a known oncogenic driver alteration other than ROS1. 2. Known allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4 weeks of first dose of study drug. 4. Ongoing or recent anticancer therapy. 5. Ongoing or recent radiation therapy within the following timeframe prior to first dose of study drug. Please refer to the protocol for further criteria.
研究者
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