Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called EGL-001 for patients with certain types of advanced or metastatic solid tumors. These are cancers that have spread from their original location to other parts of the body. The treatment, EGL-001, is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of EGL-001 in treating these advanced cancers. The study is divided into two parts. In the first part, researchers will determine the safest dose of EGL-001 by gradually increasing the amount given to patients and observing any side effects. In the second part, the study will explore how well the treatment works, either on its own or in combination with another type of cancer treatment known as an anti-PD(L)-1, which helps the immune system fight cancer cells.

Participants in the study will receive the treatment over a period of time, and researchers will monitor their health and response to the treatment. The study aims to find out how the treatment affects the cancer and any side effects that may occur. This information will help determine if EGL-001 could be a beneficial treatment option for patients with these types of cancers in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient provides signed written informed consent, confirming understanding of the trial's nature and potential consequences.
A negative blood pregnancy test is required for women of childbearing potential at the screening stage.
Step 2
Initial assessment
The patient undergoes an initial assessment to confirm eligibility, including evaluation of performance status, life expectancy, and recovery from previous treatments.
The patient must have at least one measurable lesion and adequate hematological, hepatic, and renal functions.
Step 3
Treatment phase 1: dose escalation
The patient receives EGL-001 via intravenous infusion. The primary goal is to evaluate safety, tolerability, and identify the maximum tolerated dose.
The patient is monitored for dose-limiting toxicities and adverse events during this phase.
Step 4
Treatment phase 2: dose expansion
The patient continues to receive EGL-001 at the recommended dose, potentially in combination with an anti-PD(L)-1 therapy.
The focus is on evaluating the preliminary efficacy, specifically the objective response rate.
Step 5
Monitoring and follow-up
Throughout the study, the patient is regularly monitored for adverse events and treatment-emergent adverse events.
The patient is assessed for overall response rate, disease control rate, duration of response, progression-free survival, and overall survival.
Step 6
Post-treatment observation
After the last dose of the study drug, the patient is observed for up to 90 days to monitor any late-onset adverse events.
The patient must refrain from donating blood and, if male, sperm, for a specified period after treatment.

Who can join the trial?

13 criteria

Must provide a signed written informed consent, which means you agree to participate after understanding the study.
Must be a female or male patient, aged at least 18 years.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates you are fully active or have some symptoms but can carry out light work.
Must have a life expectancy of at least 3 months as assessed by the doctor.
Must have confirmed locally advanced, unresectable, or metastatic solid tumors, which means the cancer has spread and cannot be removed by surgery, and have been previously treated with standard care but are no longer eligible for other therapies.
Must have been treated with an immune checkpoint inhibitor (ICI) treatment, either alone or in combination, as part of standard care.
Must have recovered from previous treatment.
Must have at least one measurable lesion according to RECIST Version 1.1, which is a way to measure the size of tumors.
Must have adequate hematological (blood), hepatic (liver), and renal (kidney) functions.
For women of childbearing potential, must have a negative blood pregnancy test at screening.
Must use highly effective contraception during the study and for 6 months after the last study treatment if you are a woman of childbearing potential or a male patient who is sexually active with a woman of childbearing potential. This includes methods like hormonal contraceptives, intrauterine devices, tubal ligation, or vasectomy. Male patients must also use a condom during the study and for 3 months after the last treatment and must not donate sperm.
Must agree not to donate blood while taking the study drug and for 3 months after stopping the treatment.
Must be able to understand the nature and consequences of the clinical trial.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with advanced and/or metastatic solid tumors. This means the cancer has not spread to other parts of the body.
Patients who are not adults. The study is only for adult patients.
Patients who are not able to safely tolerate the treatment. This means if the treatment could cause harm, they cannot participate.
Patients who are part of a vulnerable population that may not be able to give informed consent or understand the study. This includes people who might not fully understand what participating in the study means.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centr Georges Francois Leclerc
Verified
Dijon, France
Hospital Universitario De Navarra
Verified
Pamplona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

Trial locations

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Investigated drugs

EGL-001
is an investigational medication being studied for its potential to treat advanced or metastatic solid tumors. The trial aims to determine the safety and tolerability of this medication, as well as to find the most effective dose that patients can tolerate. Researchers are also looking at how well the medication works in shrinking tumors or stopping their growth.
Anti-PD(L)-1
is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells. In this trial, it is being used in combination with EGL-001 to see if the combination is more effective in treating advanced or metastatic solid tumors compared to using EGL-001 alone.

What is already known about the treatment

EGL-001 – EGL-001 is an investigational medication currently being studied in clinical trials for its potential use in treating advanced and metastatic solid tumors. It is administered to patients in a clinical setting, typically through intravenous infusion. The medication is in the early stages of research, with ongoing studies evaluating its safety, tolerability, and effectiveness. EGL-001 is designed to target specific pathways involved in tumor growth and survival, potentially inhibiting cancer progression. It falls under the pharmacological classification of targeted cancer therapies, aiming to disrupt molecular mechanisms that allow cancer cells to thrive.

Investigated diseases

Advanced and Metastatic Solid Tumors – These are a group of cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. The term "advanced" indicates that the cancer has grown significantly or spread locally, while "metastatic" means it has spread to distant organs or tissues. These tumors can arise in various parts of the body, such as the lungs, liver, or bones. As the disease progresses, it can lead to symptoms depending on the location and size of the tumors. The progression often involves the cancer cells invading nearby tissues and entering the bloodstream or lymphatic system, which facilitates their spread to other areas. The behavior and progression of these tumors can vary widely depending on the type of cancer and individual patient factors.