A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

JRCT ID: jRCT2031230693

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced NSCLC and Other Solid Tumors
• Date of first enrollment: 01/04/2024
• Target sample size: 15
• Countries of recruitment: USA,Japan,UK,Japan,Italy,Japan,Australia,Japan,Belgium,Japan,Canada,Japan,France,Japan,Netherlands,Japan,Spain,Japan,Germany,Japan,Taiwan,Japan,Singapore,Japan,South Korea,Japan
• Study type: Interventional

Intervention(s)

IMP: NVL-520
NVL-520 is a tablet taken by mouth.
Patients will receive study drug continuously from first dose until disease progression, unacceptable toxicity, withdrawal by patient, or Investigator's decision.
Patients who are deriving clinical benefit in the opinion of the Investigator may continue to receive NVL-520 following disease progression at the discretion of the Investigator in consultation with the Sponsor.

Outcome(s)

Primary Outcome

Maximum tolerated dose (Phase 1): Highest dose with dose-limiting toxicity (DLT) rate =< 25%
RP2D: To determine the RP2D
Objective Response Rate (ORR) (Phase 2): To determine ORR as assessed by BICR

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Age >=18 years (Cohort 2e only: Age >=12 years and weighing>40 kg).
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.
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.
Prior therapy requirements
Cohort 2a: ROS1-positive NSCLC naive to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy.
Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy.
Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy.
Cohot 2d: ROS1-positive NSCLC treated with >=2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy.
Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Exclude 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.

Related Information

• Primary Sponsor: Upadhyay Vivek