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Tas3351

A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of TAS3351, a novel oral medication for patients with advanced non-small cell lung cancer (NSCLC) who have developed a specific mutation called C797S in the epidermal growth factor receptor (EGFR). This study aims to determine the optimal dosage and explore the potential benefits of TAS3351 in improving outcomes for patients with this challenging form of lung cancer.

Table of Contents

What is TAS3351?

TAS3351 is a new drug that is currently being studied for the treatment of advanced non-small cell lung cancer (NSCLC). It is designed to be taken orally, which means patients can swallow it as a pill or capsule[1]. This medication is specifically targeted at patients whose cancer has a particular genetic change called an EGFR mutation, especially one known as C797S[1].

Target Condition: Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. In some cases of NSCLC, the cancer cells have changes (mutations) in a gene called EGFR (Epidermal Growth Factor Receptor). These mutations can cause the cancer to grow and spread more quickly. TAS3351 is being developed to target NSCLC that has a specific EGFR mutation called C797S, which can occur after treatment with other EGFR-targeting drugs[1].

How TAS3351 Works

While the exact mechanism of TAS3351 is not fully described in the available information, it is designed to target NSCLC with the C797S EGFR mutation. This mutation can make the cancer resistant to other treatments, so TAS3351 aims to overcome this resistance and stop or slow down the growth of cancer cells[1].

Clinical Trial Overview

TAS3351 is currently being studied in a clinical trial that has three parts[1]:

  1. Part A (Dose Escalation): This part aims to find the safest and most effective dose of TAS3351[1].
  2. Part B (Dose Expansion): This part will further explore how well TAS3351 works in patients with NSCLC that has the C797S EGFR mutation[1].
  3. Part C (Phase 2): This part will assess how effective TAS3351 is in treating NSCLC patients with the C797S EGFR mutation[1].

Trial Objectives

The main goals of this clinical trial are[1]:

  • Safety: To determine if TAS3351 is safe for patients to take and what the best dose might be.
  • Efficacy: To see how well TAS3351 works in treating NSCLC. This includes measuring things like:
    • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
    • Duration of Response (DoR): How long the cancer remains smaller or gone after treatment.
    • Progression-Free Survival (PFS): How long patients live without their cancer getting worse.
    • Overall Survival (OS): How long patients live overall.
  • Pharmacokinetics: To understand how the drug moves through and is processed by the body.

Potential Benefits of TAS3351

While it’s important to note that TAS3351 is still in the testing phase, researchers hope it may offer several potential benefits[1]:

  • It may be effective against NSCLC that has become resistant to other treatments.
  • It’s taken orally, which could be more convenient for patients than treatments given by injection or infusion.
  • It may help control the growth and spread of lung cancer in patients with the specific C797S EGFR mutation.
  • It could potentially improve survival and quality of life for patients with advanced NSCLC.

Safety Considerations

As with any new medication, safety is a top priority in the TAS3351 clinical trial. The researchers will be closely monitoring for any side effects or adverse events throughout the study. They will be looking at what they call “dose-limiting toxicities,” which are side effects that are severe enough to limit how much of the drug can be given safely[1].

Patient Involvement in the Study

Patients participating in the later stages of the trial may be asked to complete questionnaires about their experiences. This is part of what researchers call “patient-reported outcomes” (PROs). These questionnaires help researchers understand how the treatment affects patients’ quality of life and overall well-being[1].

Aspect Details
Drug Name TAS3351
Administration Oral (by mouth)
Target Condition Advanced or metastatic non-small cell lung cancer (NSCLC) with C797S EGFR mutation
Study Design Phase 1/2, open-label, first-in-human
Study Parts Part A: Dose Escalation, Part B: Dose Expansion, Part C: Phase 2
Primary Outcomes Safety, recommended Phase 2 dose, Objective Response Rate (ORR)
Secondary Outcomes Duration of Response, Disease Control Rate, Progression-Free Survival, Overall Survival, Pharmacokinetics, Intracranial Response
Estimated Study Duration Up to 3 years

FAQ

  • What is TAS3351 and how is it administered? TAS3351 is a new oral medication being studied for the treatment of advanced non-small cell lung cancer. It is taken by mouth, making it convenient for patients to use.
  • Who is eligible for this clinical trial? The trial is designed for patients with advanced or metastatic non-small cell lung cancer who have developed a specific mutation called C797S in the EGFR gene. This mutation typically occurs after previous treatments for EGFR-mutated lung cancer.
  • What are the main goals of this clinical trial? The primary goals are to determine the safety of TAS3351, find the best dose for future studies, and evaluate how well it works in treating patients with NSCLC that has the C797S EGFR mutation.
  • How is the effectiveness of TAS3351 measured in this study? The main measure of effectiveness is the Objective Response Rate (ORR), which looks at how many patients' tumors shrink or disappear after treatment. Other measures include how long the response lasts, how long patients live without their cancer getting worse, and overall survival.
  • What are the different parts of this clinical trial? The trial has three parts: Part A (dose escalation) to find the right dose, Part B (dose expansion) to further explore how well it works, and Part C (Phase 2) to confirm its effectiveness in a larger group of patients.

Ongoing Clinical Trials on Tas3351

  • Study of TAS3351 for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations

    Not recruiting

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

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form, 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 on the surface of cells that helps them grow and divide. Some NSCLC tumors have mutations in the EGFR gene, which can affect how the cancer grows and responds to treatment.
  • C797S mutation: A specific change in the EGFR gene that can occur after treatment with certain lung cancer medications. This mutation can make the cancer resistant to some treatments.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment. It's a way to measure how well a treatment is working.
  • Duration of Response (DoR): The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
  • 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 the start of treatment that patients diagnosed with the disease are still alive.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are serious enough to prevent an increase in dose or require a dose to be reduced.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Intracranial: Referring to the area inside the skull, particularly the brain. In this study, it relates to how the drug affects tumors that have spread to the brain.

References