Ph I/II Highly Selective ROS1 Inhibitor NUV=520 in Pts w/ Adv NSCLC & Other Solid Tumors
Study 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/or 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
Eligibility
Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).
Phase 1:
Histologically or cytologically confirmed metastatic solid tumor with documented ROS1 rearrangement.
Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed metastatic NSCLC with ROS1 rearrangement.
Cohort 2e: Histologically or cytologically confirmed metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
Prior anticancer treatment (except cohort 2a).
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.
Adequate baseline organ function and bone marrow reserve.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.