Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

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.

Official 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)

Details

In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts: - Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy. - Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior platinum-based chemotherapy with or without immunotherapy. - Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. - Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior platinum-based chemotherapy with or without immunotherapy. - Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Keywords

Locally Advanced Solid Tumor Metastatic Solid Tumor Neoplasms NVL-520

Eligibility

You can join if…

Open to people ages 12 years and up

  1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).
  2. Phase 1:
  3. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
  4. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
  5. Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
  6. Prior anticancer treatment (except cohort 2a).
  7. 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.

  1. Adequate baseline organ function and bone marrow reserve.

You CAN'T join if...

  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.

Locations

  • UCI Medical Center accepting new patients
    Orange California 92868 United States
  • University of Colorado Cancer Center accepting new patients
    Denver Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nuvalent Inc.
ID
NCT05118789
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 247 study participants
Last Updated