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Cln-081

CLN-081, also known as TAS6417 or zipalertinib, is an investigational drug currently being studied in clinical trials for patients with non-small cell lung cancer (NSCLC) who have a specific genetic mutation called EGFR exon 20 insertion. This article will explore the ongoing research, potential benefits, and important information about CLN-081 in its clinical trial journey.

Table of Contents

What is CLN-081?

CLN-081, also known as TAS6417 or zipalertinib, is a new drug being studied for the treatment of a specific type of lung cancer[1]. It is designed to target a particular genetic mutation found in some lung cancer patients, offering hope for more effective and targeted treatment options.

Target Condition: NSCLC with EGFR Exon 20 Insertion Mutations

CLN-081 is being developed to treat non-small cell lung cancer (NSCLC) with a specific genetic change called EGFR exon 20 insertion mutations[1]. To understand this better:

  • Non-small cell lung cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers.
  • EGFR (Epidermal Growth Factor Receptor): This is a protein on cells that helps them grow and divide. Some NSCLC cells have too much EGFR, which makes them grow faster.
  • Exon 20 insertion mutations: These are specific changes in the EGFR gene that can make lung cancer cells grow and spread more aggressively.

Clinical Trial Overview

The clinical trial for CLN-081 is a Phase 1/2 study, which means it’s in the early stages of testing in humans[1]. The trial is designed to:

  1. Determine if CLN-081 is safe for patients
  2. Find the right dose of the drug
  3. See how well it works against NSCLC with EGFR exon 20 insertion mutations

This trial is particularly important for patients who have already received platinum-based chemotherapy, as it may offer a new treatment option for those who have not responded well to standard treatments[1].

Trial Objectives

The clinical trial is divided into several parts, each with specific goals[1]:

  • Phase 1 Dose Escalation: To find the safest and most effective dose of CLN-081
  • Phase 2a Dose Expansion: To further test the chosen dose in more patients
  • Module A: To see how food affects how the body processes CLN-081
  • Module B: To study CLN-081 in patients who have received other cancer treatments before
  • Module C: To explore how CLN-081 works in patients who have already tried other drugs specifically approved for EGFR exon 20 insertion mutant NSCLC

Dosing and Administration

CLN-081 is given as a tablet that patients take by mouth twice daily (BID)[1]. The exact dose may vary depending on which part of the trial a patient is in. Some parts of the study are also looking at how taking the drug with or without food might affect its effectiveness.

Safety and Efficacy Measures

The researchers are carefully monitoring several aspects of CLN-081’s performance[1]:

  • Safety: They’re tracking any side effects (called adverse events or AEs) that patients experience.
  • Efficacy: They’re measuring how well the drug works by looking at:
    • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
    • Duration of response (DOR): How long the cancer stays smaller or gone after treatment.
    • Disease control rate (DCR): The percentage of patients whose cancer shrinks or stays the same size.
    • Progression-free survival (PFS): How long patients live without their cancer getting worse.
    • Overall survival (OS): How long patients live overall.
  • Pharmacokinetics: They’re studying how the body processes the drug by measuring things like how much of the drug gets into the bloodstream and how long it stays there.

Potential Benefits for Patients

While it’s important to remember that CLN-081 is still in the testing phase, it offers several potential benefits for patients with NSCLC and EGFR exon 20 insertion mutations[1]:

  • It may provide a new treatment option for patients who have not responded well to other therapies.
  • As a targeted therapy, it may have fewer side effects than traditional chemotherapy.
  • It’s taken orally, which can be more convenient for patients than treatments given by injection or infusion.
  • If successful, it could improve survival and quality of life for patients with this specific type of lung cancer.

As research continues, more information about CLN-081’s effectiveness and safety will become available, potentially offering new hope for lung cancer patients with this specific genetic mutation.

Aspect Details
Drug Name CLN-081 (also known as TAS6417 or zipalertinib)
Target Condition Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutations
Trial Phase Phase 1/2
Administration Oral tablets, twice daily (BID)
Primary Objectives Safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy
Key Outcomes Measured Adverse events, dose-limiting toxicities, overall response rate, duration of response
Trial Structure Multiple parts including dose escalation, dose expansion, and food effect study
Patient Population NSCLC patients with EGFR exon 20 insertion mutations, including those who have received prior treatments

FAQ

  • What is CLN-081 and what is it being studied for? CLN-081 is an investigational drug being studied for the treatment of non-small cell lung cancer (NSCLC) in patients who have a specific genetic mutation called EGFR exon 20 insertion. It is designed to target this particular mutation, which is not effectively treated by many existing lung cancer therapies.
  • What phase of clinical trials is CLN-081 currently in? CLN-081 is currently being studied in a Phase 1/2 clinical trial. This means it is in the early stages of testing in humans, focusing on safety, dosing, and preliminary effectiveness.
  • How is CLN-081 administered to patients in the trial? In the clinical trial, CLN-081 is given as tablets that patients take by mouth twice daily (BID).
  • What are the main goals of the CLN-081 clinical trial? The main goals of the trial are to assess the safety and tolerability of CLN-081, determine the best dose for future studies, evaluate how the drug moves through the body (pharmacokinetics), and measure its effectiveness in treating NSCLC with EGFR exon 20 insertion mutations.
  • Who can participate in the CLN-081 clinical trial? The trial is primarily for patients with locally-advanced or metastatic non-small cell lung cancer who have an EGFR exon 20 insertion mutation. Some parts of the study focus on patients who have previously received platinum-based chemotherapy or other treatments for this specific type of lung cancer.

Ongoing Clinical Trials on Cln-081

  • Study of CLN-081 tablets in patients with non-small cell lung cancer with EGFR exon 20 insertion mutations who have previously received platinum chemotherapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy The Netherlands Spain

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • EGFR (Epidermal Growth Factor Receptor): A protein found on the surface of some cells that helps them grow and divide. In some types of cancer, including certain lung cancers, there can be too much EGFR, causing cancer cells to grow more quickly.
  • Exon 20 Insertion Mutation: A specific type of genetic change in the EGFR gene that can lead to lung cancer. It's called an 'insertion' because extra genetic material is inserted into a part of the gene called exon 20.
  • Phase 1/2 Trial: An early stage of clinical research that combines elements of both Phase 1 (which focuses on safety and dosing) and Phase 2 (which begins to look at effectiveness) studies.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined in early clinical trials to be appropriate for further testing in larger Phase 2 studies.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or that require a decrease in dose in clinical trials.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to a therapeutic intervention.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients are still alive.

References