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Ep0031

A groundbreaking clinical trial is underway to evaluate the potential of EP0031, a new drug designed to target advanced RET-altered malignancies. This study aims to assess the safety, side effects, and effectiveness of EP0031 in patients with various types of advanced solid tumors. The trial is particularly focused on patients who have progressed on first-generation selective RET inhibitors (SRIs) and those who have not received prior SRI therapy.

Table of Contents

What is EP0031?

EP0031 is a new medication being studied for the treatment of certain types of cancer[1]. It is described as a potent next-generation selective RET-inhibitor (SRI). To understand this, let’s break it down:

  • RET-inhibitor: This means the drug targets and blocks a specific protein called RET, which is involved in some types of cancer.
  • Next-generation: EP0031 is designed to be more effective than earlier treatments that target RET.
  • Selective: The drug is designed to specifically target RET, potentially reducing side effects on other parts of the body.

How Does EP0031 Work?

EP0031 works by targeting cancers that have changes (alterations) in the RET gene[1]. These alterations can cause cancer cells to grow and spread. By blocking the effects of these RET alterations, EP0031 aims to slow down or stop the growth of cancer cells.

Importantly, EP0031 is designed to be effective against a wide range of RET alterations, including both RET fusions and RET mutations[1]. This means it could potentially help patients with different types of RET-altered cancers.

What Cancers Can EP0031 Treat?

EP0031 is being studied for the treatment of several types of advanced RET-altered malignancies (cancers with changes in the RET gene that have spread or are in late stages)[1]. These include:

  • RET fusion-positive Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer with specific RET gene changes.
  • RET mutation-positive Medullary Thyroid Cancer (MTC): A type of thyroid cancer with RET gene mutations.
  • Other RET-altered solid tumors: This could include various types of cancers that have RET gene changes.

Clinical Trial Details

EP0031 is currently being studied in a clinical trial to determine its safety and effectiveness[1]. Here are some key points about the trial:

  • It’s a Phase I/II study, which means it’s testing both the safety and effectiveness of the drug.
  • The study is “modular” and “open-label”, meaning it has different parts and participants know they’re receiving EP0031.
  • Patients take EP0031 capsules once daily until their disease progresses, they experience unacceptable side effects, or they choose to withdraw from the study.
  • The study includes patients who have previously received first-generation SRI therapy and those who haven’t.

Expected Outcomes

The clinical trial is looking at several important outcomes[1]:

  1. Safety: The study will measure how many patients experience serious side effects (called Dose-Limiting Toxicities or DLTs) in the first 28 days of treatment.
  2. Effectiveness: The study will measure the Overall Response Rate (ORR), which shows how many patients’ tumors shrink or disappear after treatment.
  3. How the body processes the drug (pharmacokinetics):
    • How much of the drug is in the blood over time (AUC)
    • The highest level of the drug in the blood (Cmax)
    • How long it takes for the drug level to decrease by half (Half-life)

Safety and Side Effects

While EP0031 is designed to be more selective and potentially have fewer side effects than earlier treatments, all medications can have side effects[1]. The clinical trial is carefully monitoring patients for any side effects, especially in the first 28 days of treatment.

It’s important to note that EP0031 is still being studied, and we don’t yet know all of its potential side effects. Patients in the trial will be closely monitored by their healthcare team.

Aspect Details
Drug Name EP0031
Drug Type Potent next-generation selective RET inhibitor (SRI)
Target Conditions Advanced RET-altered malignancies, including NSCLC, MTC, and other solid tumors
Study Phase Phase I/II
Administration Oral capsules, once daily
Primary Outcomes Incidence of Dose-limiting Toxicity, Overall Response Rate
Secondary Outcomes Pharmacokinetics (AUC, Cmax, Half-life)
Patient Groups Prior SRI therapy and SRI-naive patients

FAQ

  • What is EP0031 and how does it work? EP0031 is a potent next-generation selective RET inhibitor (SRI). It works by targeting and inhibiting the RET gene, which is altered in certain types of cancer. EP0031 is designed to be more effective than first-generation SRIs and may overcome resistance mechanisms to these earlier treatments.
  • What types of cancer is EP0031 being tested for? EP0031 is being tested for advanced RET-altered malignancies, which include RET fusion-positive non-small cell lung cancer (NSCLC), RET mutation-positive medullary thyroid cancer (MTC), and other RET-altered solid tumors.
  • How is the drug administered in the trial? In the trial, EP0031 is given as capsules taken once daily. Patients continue taking the drug until they experience disease progression, unacceptable side effects, or choose to withdraw from the study.
  • What are the main goals of this clinical trial? The main goals of the trial are to determine the safety and tolerability of EP0031, find the optimal dose, study how the drug behaves in the body (pharmacokinetics), and evaluate its effectiveness in treating RET-altered cancers.
  • Who can participate in this clinical trial? The trial is open to adult patients with advanced RET-altered malignancies. This includes patients who have previously been treated with first-generation SRIs and those who have not received prior SRI therapy. Specific eligibility criteria would be determined by the study investigators.

Ongoing Clinical Trials on Ep0031

  • A study of EP0031 and drug combination for patients with advanced cancers having changes in the RET gene

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • RET: A gene that, when altered, can contribute to the development of certain cancers. RET stands for 'rearranged during transfection'.
  • SRI: Selective RET Inhibitor. A type of drug that specifically targets and blocks the activity of altered RET genes in cancer cells.
  • NSCLC: Non-Small Cell Lung Cancer. A type of lung cancer that is the most common form of the disease.
  • MTC: Medullary Thyroid Cancer. A rare type of thyroid cancer that begins in cells in the thyroid that produce hormones.
  • Dose-limiting Toxicity (DLT): Side effects of a treatment that are severe enough to prevent an increase in dose or require a dose to be reduced.
  • RECIST: Response Evaluation Criteria in Solid Tumors. A standard way to measure how well a cancer patient responds to treatment.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • AUC: Area Under the Curve. A measure used in pharmacokinetics to show the total exposure to a drug over time.
  • Cmax: Maximum Concentration. The highest concentration of a drug in the blood after it's been administered.
  • Half-life: The time it takes for the concentration of a drug in the body to reduce by half.

References