A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

uvalent, Inc.0 个研究点目标入组 246 人开始时间: 2021年8月26日最近更新: 2021年12月6日

研究概览

暂无简介。

•Patients must meet all of the following criteria to be eligible to enroll in the study:
•1. Age > or =18 years (Cohort 2e only: Age > or =12 years and weighing>40 kg).
•2. Phase 1: a. Histologically or cytologically confirmed metastatic solid tumor with documented ROS1 rearrangement
•b. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed metastatic NSCLC with ROS1 rearrangement
•c. Cohort 2e: Histologically or cytologically confirmed metastatic solid tumor (other than NSCLC) with ROS1 rearrangement
•3. Must have received Prior anticancer treatment (except for cohort 2a)
•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. In all study parts, patients with asymptomatic CNS-only measurable disease =10 mm as defined by RECIST 1.1 are eligible.
•5. Adequate baseline organ function and bone marrow reserve
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Patient’s cancer has a known primary driver alteration other than ROS1.
•2. Known allergy/hypersensitivity to excipients of NVL-520.
•3. Major surgery within 4 weeks of study entry.
•4. Ongoing or recent anticancer therapy
•5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study

发起方

uvalent, Inc.