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Protocol NumberNVL-520-01
NCT Number(ClinicalTrials.gov Identfier)NCT05118789
Active

2023-02-23 - 2026-10-31

Phase I

Not yet recruiting1

Recruiting3

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

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Cancer Center

Co-Principal Investigator

  • 黃信端 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally Advanced Solid Tumor、 Metastatic Solid Tumor

Objectives

Purpose of Issue 1: main purpose ‧ Determination of RP2D and, if applicable, maximum tolerated dose (MTD) of NVL-520 in patients with ROS1-positive advanced solid tumors secondary purpose ‧ Evaluate the overall safety and tolerability of NVL-520 ‧ Determination of PK profile of NVL-520 ‧ To evaluate the preliminary anti-tumor activity of NVL-520 in patients with ROS1-positive advanced solid tumors Purpose of Issue 2: main purpose ‧ Evaluate the ORR of NVL-520 in RP2D in patients with ROS1-positive advanced NSCLC and other solid tumors secondary purpose ‧ Evaluate other clinical efficacy indicators in patients with ROS1-positive NSCLC and other solid tumors ‧ To evaluate the intracranial anti-tumor activity of NVL-520 at RP2D in patients with ROS1-positive advanced NSCLC and other solid tumors ‧ Understand the safety and tolerability of NVL-520 in RP2D ‧ Confirm the PK profile of NVL-520 in RP2D

Test Drug

NVL-520

Active Ingredient

NVL-520

Dosage Form

Tablet

Dosage

100 mg
25 mg

Endpoints

Phase 1 evaluation indicators:
Main evaluation indicators
‧ RP2D and, if applicable, MTD, based on DLT incidence during cycle 1, overall safety profile, PK, PD, and preliminary efficacy

Phase 2 evaluation indicators:
Main evaluation indicators
‧ ORR, according to RECIST 1.1
? It is defined as the proportion of patients with confirmed CR or PR among patients with measurable disease confirmed by the Blinded Independent Central Review Committee (BICR) during the base period, as assessed by BICR according to RECIST 1.1

Inclution Criteria

Inclusion Criteria:

Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).
Disease Criteria:

Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or 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.

Exclusion Criteria

Exclusion Criteria:

Patient's cancer has a known oncogenic driver alteration other than ROS1.
Known allergy/hypersensitivity to excipients of NVL-520.
Major surgery within 4 weeks of first dose of study drug.
Ongoing anticancer therapy.
Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    700 participants

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