ARROS-1
Research type
Research Study
Full title
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
IRAS ID
1006186
Contact name
Virginia Vetter
Contact email
Sponsor organisation
Nuvalent, Inc.
Eudract number
2021-002477-26
Clinicaltrials.gov Identifier
Research summary
This is a first in human (FIH), Phase 1/2, multicentre, open-label, 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 NSCLC and other advanced ROS1-positive solid tumours. Approximately 12 sites in the United States and Europe are planned for Phase1 and approximately 60 sites globally for Phase 2.
In Phase 1 of the clinical trial, the safety of NVL-520 will be tested at different dose levels, in about 54 patients. The first three patients to enrol in the trial will receive the lowest dose of NVL-520; and depending on how the drug is tolerated, subsequent patient groups will receive gradually increased doses until a dose that shows preliminary antitumor activity with least side effects is found. A safety committee will determine if it is safe to increase the dose or may recommend keeping the dose the same or lower it for subsequent patients.
Once preliminary antitumor activity and a safe dose is determined, then the study will move to the second part of the study. About 193 patients are planned to be enrolled in the Phase 2 part of the study. Several different groups (defined by prior treatments received and tumour type) will be treated with the dose selected in the Phase 1 part of the study to further investigate how safe NVL-520 is for patients and how well it works.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0316
Date of REC Opinion
19 May 2023
REC opinion
Further Information Favourable Opinion