A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
- Conditions
- Advanced ROS1-positive NSCLC and other advanced ROS1-positive solid tumorsTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511793-71-00
- Lead Sponsor
- uvalent Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 249
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method