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Zidesamtinib

Zidesamtinib, also known as NVL-520, is an innovative drug currently being studied in clinical trials for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. This highly selective ROS1 inhibitor shows potential in treating cancers with specific genetic alterations, offering hope for patients with limited treatment options.

Table of Contents

What is ZIDESAMTINIB?

ZIDESAMTINIB, also known as NVL-520, is a new medication being studied for the treatment of certain types of cancer[1]. It is classified as a highly selective ROS1 inhibitor. ROS1 is a protein that, when altered, can contribute to the growth of cancer cells. By targeting this specific protein, ZIDESAMTINIB aims to stop or slow down the progression of cancers that are driven by ROS1 alterations.

This drug is also known by several other names, including:[1]

  • NUV-520
  • (6R)-22-Ethyl-54-fluoro-42,6-dimethyl-22H,42H-7-oxa-1(3,5)-pyridina-2(3,4)-pyrazola-4(4,5)-[1,2,3]triazola-5(1,2)-benzenacycloheptaphan-16-amine
  • (R)-3-Ethyl-16-fluoro-10-methyl-19-methyl-20-oxa-3,4,9,10,11,23-hexaazapentacyclo[19.3.1.02,6.08,12.013,18]pentacosa-1(24),2(6),4,8,11,13,15,17,21(25),22-decaen-22-ylamine
These are scientific names that describe the chemical structure of the drug.

Medical Conditions Treated

ZIDESAMTINIB is being studied for the treatment of:[1]

  • Advanced ROS1-positive Non-Small Cell Lung Cancer (NSCLC): This is a type of lung cancer that has a specific genetic change involving the ROS1 gene.
  • Other advanced ROS1-positive solid tumors: This includes various types of cancers that have spread (metastasized) and have the ROS1 genetic alteration.

How ZIDESAMTINIB Works

ZIDESAMTINIB is designed to work as a highly selective ROS1 inhibitor. Here’s what this means:[1]

  • ROS1: This is a protein that, when altered, can act as a “switch” that promotes cancer growth.
  • Inhibitor: The drug works by blocking or inhibiting the action of the altered ROS1 protein.
  • Highly selective: This means the drug is designed to specifically target ROS1, potentially reducing side effects caused by affecting other proteins.
By blocking the action of the altered ROS1 protein, ZIDESAMTINIB aims to slow down or stop the growth of cancer cells that depend on this protein for their survival and growth.

Clinical Trial Overview

ZIDESAMTINIB is currently being studied in a clinical trial called ARROS-1. This is a Phase 1/2 study, which means it’s designed to test both the safety and effectiveness of the drug[1]. The trial is divided into two main phases:

Phase 1 Objectives:[1]

  • Determine the right dose of ZIDESAMTINIB for future studies (called the Recommended Phase 2 Dose or RP2D)
  • Find out the highest dose that can be given safely (Maximum Tolerated Dose or MTD)
  • Evaluate the overall safety and how well patients tolerate the drug
  • Study how the drug moves through the body (pharmacokinetics)
  • Look for early signs of the drug’s effectiveness against tumors

Phase 2 Objectives:[1]

  • Measure how well the drug works against tumors (Overall Response Rate or ORR)
  • Further assess the drug’s effectiveness in lung cancer and other solid tumors
  • Evaluate how well the drug works against tumors in the brain
  • Continue to study the safety and how patients tolerate the drug
  • Assess how the treatment affects patients’ symptoms and quality of life

Eligibility Criteria

To participate in the ZIDESAMTINIB clinical trial, patients must meet certain criteria. Here are some key eligibility requirements:[1]

Inclusion Criteria:

  • Age: 18 years or older (12 years or older for a specific part of the study)
  • Diagnosis: Advanced or metastatic solid tumor with a ROS1 rearrangement (a specific genetic change)
  • Measurable disease: The cancer must be able to be measured on scans
  • Prior treatment: Patients must have received or be ineligible for standard treatments

Exclusion Criteria:

  • Other genetic changes: Patients whose cancer has known genetic drivers other than ROS1 are not eligible
  • Recent surgeries or other cancer treatments: Patients who have had major surgery or certain other treatments recently may not be eligible
  • Allergies: Known allergies to components of ZIDESAMTINIB

It’s important to note that these are just some of the criteria. A healthcare provider can provide more detailed information about eligibility for the trial.

Potential Benefits

While the full benefits of ZIDESAMTINIB are still being studied, the clinical trial aims to evaluate several potential advantages:[1]

  • Tumor shrinkage: The study will measure how well the drug can shrink tumors (Overall Response Rate)
  • Brain metastases: ZIDESAMTINIB will be evaluated for its ability to treat cancer that has spread to the brain
  • Quality of life: The study will assess how the treatment affects patients’ symptoms and overall health status
  • Targeted approach: As a highly selective ROS1 inhibitor, ZIDESAMTINIB may potentially offer effective treatment with fewer side effects compared to less selective treatments

Safety and Side Effects

As ZIDESAMTINIB is still in clinical trials, its full safety profile is not yet known. The study is designed to carefully monitor and assess the safety of the drug. Some key points about safety:[1]

  • The trial will track the occurrence and severity of side effects (called adverse events)
  • Changes in laboratory test results will be monitored
  • The study will determine the highest dose that can be given safely
  • Patients will be closely monitored throughout the trial
It’s important to remember that all medications can have side effects, and the purpose of this clinical trial is partly to better understand the safety profile of ZIDESAMTINIB.

Administration

ZIDESAMTINIB is administered as a tablet to be taken by mouth (oral use)[1]. The exact dosing schedule will be determined as part of the clinical trial. Patients in the trial will receive clear instructions on how and when to take the medication.

Aspect Details
Drug Name Zidesamtinib (NVL-520)
Drug Type Highly selective ROS1 inhibitor
Target Conditions Advanced ROS1-positive NSCLC and other solid tumors
Study Phase Phase 1/2
Main Objectives Determine RP2D, evaluate ORR, assess safety and efficacy
Administration Oral tablet
Key Eligibility Criteria Age ≥18 years (≥12 for some cohorts), ROS1-positive tumors, measurable disease
Primary Endpoints RP2D, MTD, ORR per RECIST 1.1
Secondary Endpoints Safety profile, PK parameters, intracranial activity, patient-reported outcomes

FAQ

  • What is Zidesamtinib (NVL-520)? Zidesamtinib, also known as NVL-520, is a highly selective ROS1 inhibitor being studied for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors.
  • What is the main goal of the clinical trial for Zidesamtinib? The main goal is to determine the recommended Phase 2 dose (RP2D) and evaluate the overall response rate (ORR) of Zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.
  • Who can participate in the Zidesamtinib clinical trial? Patients aged 18 and older (12 and older for some cohorts) with advanced ROS1-positive solid tumors, including NSCLC, may be eligible. Specific criteria include having measurable disease and providing pre-treatment tumor tissue.
  • What are some of the potential benefits of participating in this trial? Participants may benefit from access to a novel treatment targeting ROS1-positive cancers, potential tumor shrinkage, and contribution to advancing cancer research. The study also assesses intracranial antitumor activity and patient-reported outcomes.
  • How is Zidesamtinib administered in the clinical trial? Zidesamtinib is administered orally in tablet form. The exact dosing schedule will be determined during the Phase 1 portion of the study to establish the recommended Phase 2 dose (RP2D).

Ongoing Clinical Trials on Zidesamtinib

  • Study of NVL-520 for Patients with Advanced ROS1-Positive Lung Cancer and Other Solid Tumors

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

Glossary

  • ROS1: A gene that, when altered, can contribute to the development of certain cancers, particularly some types of lung cancer.
  • NSCLC: Non-Small Cell Lung Cancer, a type of lung cancer that accounts for about 80-85% of all lung cancers.
  • RP2D: Recommended Phase 2 Dose, the optimal dose of a drug determined in Phase 1 trials to be used in further studies.
  • MTD: Maximum Tolerated Dose, the highest dose of a drug that does not cause unacceptable side effects.
  • ORR: Overall Response Rate, the proportion of patients whose cancer shrinks or disappears after treatment.
  • DLT: Dose-Limiting Toxicity, side effects that are severe enough to prevent an increase in the dose of a drug during a clinical trial.
  • PK: Pharmacokinetics, the study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • PD: Pharmacodynamics, the study of how a drug affects the body, including its mechanism of action and effectiveness.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Intracranial antitumor activity: The effectiveness of a drug in treating tumors within the brain.
  • Patient-reported outcomes (PROs): Information about a patient's health condition that comes directly from the patient, without interpretation by doctors or others.

References

  1. http://clinicaltrials.eu/trial/study-of-nvl-520-for-patients-with-advanced-ros1-positive-lung-cancer-and-other-solid-tumors/