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Egl-001

A groundbreaking clinical trial is underway to evaluate the potential of EGL-001, a new drug being tested for patients with advanced and/or metastatic solid tumors. This first-in-human study aims to assess the safety, tolerability, and preliminary effectiveness of EGL-001 when used alone or in combination with immunotherapy. The trial represents a significant step forward in the search for new treatment options for patients with difficult-to-treat solid tumors.

Table of Contents

What is EGL-001?

EGL-001 is a new investigational drug that is currently being studied for the treatment of advanced and/or metastatic solid tumors in adults[1]. It is administered intravenously (IV), which means it is given directly into a vein[1]. As this is a first-in-human trial, EGL-001 has not been tested in humans before, and researchers are now exploring its potential benefits and risks for cancer patients.

What conditions does EGL-001 aim to treat?

The primary focus of the EGL-001 clinical trial is on adult solid tumors[1]. Solid tumors are abnormal masses of tissue that don’t contain cysts or liquid areas. They can occur in many parts of the body, such as the lungs, breast, colon, or prostate. The trial is specifically looking at patients with advanced and/or metastatic solid tumors. Here’s what these terms mean:

  • Advanced tumors: These are cancers that have grown and spread within the organ where they started.
  • Metastatic tumors: These are cancers that have spread from their original location to other parts of the body.

The trial is focusing on patients whose cancer has either recurred (come back after treatment) or metastasized (spread to other parts of the body)[1].

Current Clinical Trial of EGL-001

The ongoing clinical trial for EGL-001 is a Phase 1/2 study, which means it’s an early-stage trial designed to assess the drug’s safety and get initial data on its effectiveness[1]. This trial is being conducted in approximately 4 centers in France and 4 centers in Spain, with plans to include 30 to 50 patients in the initial phase[1].

Trial Design and Treatment Arms

The trial is divided into two main parts[1]:

  1. Part 1 (Phase 1): This is an open-label dose escalation study. In this part, researchers will test different doses of EGL-001 to find the safest and most effective dose. EGL-001 will be tested both as a single agent and in combination with an anti-PD(L)-1 treatment (a type of immunotherapy).
  2. Part 2 (Phase 2): This is an open-label dose expansion study. In this part, researchers will further test the recommended dose (determined in Part 1) in more patients with recurrent and/or metastatic solid tumors.

The trial includes several treatment arms[1]:

  • Seven different dose levels of EGL-001 as monotherapy (used alone)
  • Three different dose levels of EGL-001 in combination with an anti-PD(L)-1 treatment

Primary Objectives of the Study

The main goals of this study are to evaluate the safety and tolerability of EGL-001[1]. Researchers will be looking at:

  • Dose-limiting toxicities (DLTs): These are side effects that are severe enough to prevent increasing the dose of the drug.
  • Maximum tolerated dose (MTD): This is the highest dose that can be given without causing severe side effects.
  • Recommended Phase 2 doses (RP2Ds): These are the doses that are considered safe and potentially effective for further testing.

The study will track various safety measures, including[1]:

  • The number of DLTs at each dose level
  • The percentage of patients experiencing adverse events (AEs)
  • The percentage of patients experiencing treatment-emergent adverse events (TEAEs)
  • The percentage of patients experiencing serious adverse events (SAEs)

Secondary Objectives: Evaluating Treatment Effectiveness

While safety is the primary focus, the study will also look at how well EGL-001 works against cancer[1]. The researchers will measure:

  • Overall Response Rate (ORR): This is the percentage of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): This includes patients whose cancer shrinks or stays stable.
  • Duration of Response (DoR): This measures how long the cancer remains controlled in patients who respond to treatment.
  • Progression-Free Survival (PFS): This is the time from the start of treatment until the cancer starts growing again or the patient dies.
  • Overall Survival (OS): This measures how long patients live after starting the treatment.

These measurements will help researchers understand how effective EGL-001 is at fighting cancer and improving patients’ lives[1].

Aspect Details
Study Type Phase 1/2, first-in-human, multicenter, open-label
Drug EGL-001 (intravenous administration)
Target Population Adult patients with selected advanced and/or metastatic solid tumors
Study Design Part 1: Dose escalation (monotherapy and combination)
Part 2: Dose expansion at recommended Phase 2 dose
Treatment Arms 7 monotherapy dose levels, 3 combination therapy dose levels
Primary Outcomes Safety, tolerability, dose-limiting toxicities, maximum tolerated dose
Secondary Outcomes Overall response rate, disease control rate, duration of response, progression-free survival, overall survival
Study Locations Approximately 4 centers in France and 4 centers in Spain
Estimated Enrollment 30 to 50 patients in Part 1 (dose escalation)

FAQ

  • What is EGL-001? EGL-001 is a new drug being tested in clinical trials for patients with advanced and/or metastatic solid tumors. It is administered intravenously (through a vein) and is being studied both as a single agent and in combination with immunotherapy.
  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate the safety and tolerability of EGL-001, determine the appropriate dose for future studies, and assess its preliminary effectiveness in treating advanced solid tumors.
  • How is the trial structured? The trial is divided into two parts: Part 1 (Phase 1) involves dose escalation of EGL-001 alone and in combination with immunotherapy. Part 2 (Phase 2) will expand the study using the recommended dose determined in Part 1.
  • Who can participate in this trial? The trial is open to adult patients with selected advanced and/or metastatic solid tumors. Specific eligibility criteria will be determined by the study doctors.
  • How will the effectiveness of EGL-001 be measured? The trial will measure effectiveness through various outcomes, including the proportion of patients whose tumors shrink or disappear (overall response rate), how long the drug keeps working (duration of response), and how long patients live without their cancer getting worse (progression-free survival).

Ongoing Clinical Trials on Egl-001

  • Study of EGL-001 for Adults with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • Solid Tumor: A mass of abnormal cells that does not contain cysts or liquid areas. Solid tumors can occur in various parts of the body, such as the breast, lung, or prostate.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Open-label: A type of clinical trial where both the researchers and participants know which treatment is being given.
  • Dose escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • Monotherapy: Treatment using a single drug.
  • Combination therapy: Treatment using two or more drugs or treatment methods together.
  • Anti-PD(L)-1: A type of immunotherapy drug that helps the immune system recognize and attack cancer cells.
  • RP2D: Recommended Phase 2 Dose – the dose of a drug determined to be safe and potentially effective for further study in larger trials.
  • DLT: Dose-Limiting Toxicity – side effects severe enough to prevent an increase in the dose of a drug in a clinical trial.
  • MTD: Maximum Tolerated Dose – the highest dose of a drug that can be given without causing unacceptable side effects.
  • RECIST: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • ORR: Overall Response Rate – the percentage of patients whose cancer shrinks or disappears after treatment.
  • DCR: Disease Control Rate – the percentage of patients whose cancer shrinks, disappears, or remains stable after treatment.
  • PFS: Progression-Free Survival – the length of time during and after treatment that a patient lives without their cancer getting worse.
  • OS: Overall Survival – the length of time from the start of treatment that patients are still alive.

References

  1. https://clinicaltrials.gov/study/NCT06622486