Study #2022-0263
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)
MD Anderson Study Status
Not Accepting
Treatment Agent
NVL-520
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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Study phase:
Physician name:
George Blumenschein
Department:
Thoracic/Head & Neck Medical Oncology
For general questions about clinical trials:
1-877-430-0077
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