A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Description

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

Conditions

Locally Advanced Solid Tumor, Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

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

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Condition
Locally Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Orange

UCI Medical Center, Orange, California, United States, 92868

Palo Alto

Stanford Medicine, Palo Alto, California, United States, 94305

Sacramento

UC Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

Denver

University of Colorado Cancer Center, Denver, Colorado, United States, 80045

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Coral Gables

University of Miami, Coral Gables, Florida, United States, 33146

Boston

Mass General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Cancer Institute, Detroit, Michigan, United States, 48202

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing\>40 kg).
  • 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.
  • 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nuvalent Inc.,

Vivek Upadhyay, MD, MBI, STUDY_DIRECTOR, Nuvalent Inc.

Study Record Dates

2026-10-31