Evaluating NVL-520 for Advanced ROS1-positive Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a Phase 1/2 study designed to assess the safety, tolerability, and antitumor activity of NVL-520 in patients with advanced solid tumors that have a ROS1 rearrangement. The trial will begin with a dose escalation phase to determine the recommended phase 2 dose and maximum tolerated dose of NVL-520. Following this, the Phase 2 portion will evaluate the objective response rate and other efficacy measures in various cohorts of patients with ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. The study aims to provide insights into the effectiveness of NVL-520 in treating these specific cancer types.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years (Cohort 2e only: Age ≥12 years).
2. Disease Criteria:

   1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
   2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
   3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
3. Prior anticancer treatment (except cohort 2a).
4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.
5. Adequate baseline organ function and bone marrow reserve.

Exclusion Criteria:

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 anticancer therapy.
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Where it's running

• UCI Medical Center
  Orange, California, United States Recruiting
• Stanford Medicine
  Palo Alto, California, United States Recruiting
• UC Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• University of Colorado Cancer Center
  Denver, Colorado, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami
  Coral Gables, Florida, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nuvalent
• Email: clinicaltrials@nuvalent.com
• Phone: 857-357-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.