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Study of Eftilagimod Alpha and Paclitaxel in Patients with HER2-Negative/Low Metastatic Breast Cancer

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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 a type of breast cancer known as HER2-negative/low metastatic breast cancer. The study is testing a new treatment called eftilagimod alpha, also known by its code name IMP321. This treatment is given as a solution for injection and is being tested in combination with a standard chemotherapy drug called paclitaxel. The trial also includes a comparison group that will receive paclitaxel with a placebo.

The purpose of the study is to determine if the combination of eftilagimod alpha and paclitaxel is more effective in improving overall survival compared to paclitaxel with a placebo. Initially, the study will focus on finding the best dose of eftilagimod alpha to use with paclitaxel. After this, the main part of the study will begin, where participants will be randomly assigned to receive either the eftilagimod alpha and paclitaxel combination or paclitaxel with a placebo. The study will monitor participants over a period of time to assess the safety and effectiveness of the treatment.

Participants in the study will receive regular injections and will be closely monitored by healthcare professionals. The study aims to provide valuable information on whether eftilagimod alpha can offer a new treatment option for patients with HER2-negative/low metastatic breast cancer. The trial is expected to continue until 2027, with the goal of improving treatment outcomes for patients with this type of breast cancer.

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 will be required to provide written informed consent. This consent must be signed and dated before any study-related procedures begin.
The patient must meet specific health criteria, including having a certain type of breast cancer and being in a condition to receive the study treatments.
Step 2
Dose optimization lead-in
The initial phase involves determining the optimal dose of the study drug, eftilagimod alfa, when combined with the chemotherapy drug paclitaxel.
Patients will receive either 30 mg or 90 mg of eftilagimod alfa through subcutaneous injection, which means the drug is injected under the skin.
The goal is to evaluate the safety and tolerability of these doses and to identify the best dose for the next phase of the trial.
Step 3
Phase 3 trial
In this phase, the patient will be randomly assigned to receive either the optimal dose of eftilagimod alfa or a placebo, in combination with weekly paclitaxel chemotherapy.
The primary objective is to assess whether the combination of eftilagimod alfa and paclitaxel improves overall survival compared to paclitaxel with a placebo.
Step 4
Treatment administration
The patient will receive the study treatment on a weekly basis. The administration involves a subcutaneous injection of the study drug or placebo, along with the standard chemotherapy treatment.
The duration of the treatment will depend on the patient's response and the progression of the disease.
Step 5
Monitoring and assessments
Throughout the trial, the patient will undergo regular monitoring to assess the treatment's effects and any side effects.
This includes physical examinations, blood tests, and other necessary evaluations to ensure the patient's safety and to track the progress of the treatment.
Step 6
End of trial
The trial is expected to conclude by July 31, 2027. At the end of the trial, the patient's overall health and response to the treatment will be evaluated.
The results will contribute to understanding the effectiveness of eftilagimod alfa in combination with paclitaxel for treating metastatic breast cancer.

Who can join the trial?

14 criteria

Able to give written permission to participate and follow the study rules. This means you need to sign a form agreeing to join the study before any study-related activities begin.
Any side effects from previous treatments should be mild or gone, except for certain liver-related issues and hair loss, which can be moderate.
If you have hepatitis B, you can join if you've been on treatment for at least 4 weeks and the virus is not detectable in your blood.
If you had hepatitis C, you can join if the virus is not detectable in your blood at the start of the study.
If you have HIV, you must be on HIV medication, have a well-controlled infection, and meet specific health criteria, such as having a certain number of immune cells and a low level of the virus in your blood.
Meet specific blood test requirements, such as having enough white blood cells, platelets, and hemoglobin, and having normal liver and kidney function.
Have a specific type of breast cancer that is either hormone receptor positive or negative and HER2 negative or low, confirmed by a biopsy.
If you have hormone receptor positive breast cancer, you should have tried at least one hormone therapy and now need chemotherapy with paclitaxel.
If you have triple-negative breast cancer, you should be ready to receive paclitaxel chemotherapy without certain other treatments.
For the initial part of the study, you must be a female aged 18 or older. For the main part of the study, both males and females aged 18 or older can participate.
If you can become pregnant, you must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after the last dose of the study drug. Your partner should also use birth control. If you are postmenopausal, permanently sterilized, or unable to become pregnant, you do not need to follow these rules.
For the initial part of the study, you must have a measurable disease according to specific guidelines.
Have a good general health status, meaning you can carry out daily activities without significant limitations.
Have an expected survival of more than three months.

Who cannot join the trial?

12 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have not fully recovered from previous cancer treatments.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer in the past, except for certain types of skin cancer or cervical cancer that have been treated.
Patients who have had an organ transplant.
Patients who are taking certain medications that might interfere with the study treatment.
Patients who have a history of severe allergic reactions to similar treatments.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures for any reason.

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Verified sites

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

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium

Trial locations

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Investigated drugs

Eftilagimod Alpha
This is an experimental medication being tested in the trial. It is a soluble LAG-3 protein designed to help the immune system fight cancer. In this study, it is being combined with another medication to see if it can improve outcomes for patients with certain types of breast cancer.
Paclitaxel
This is a chemotherapy drug commonly used to treat various types of cancer, including breast cancer. It works by stopping cancer cells from dividing and growing, which can help to slow or stop the spread of the disease. In this trial, paclitaxel is used in combination with eftilagimod alpha to evaluate the effectiveness of the treatment.

What is already known about the treatment

Eftilagimod Alpha – Eftilagimod alpha is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating HER2-negative or low metastatic breast cancer. It is in the experimental phase and not yet widely available in medical practice. The main therapeutic indication is to improve overall survival in patients with this type of breast cancer when used in combination with paclitaxel. At the molecular level, eftilagimod alpha works by modulating the immune system, specifically targeting the LAG-3 protein to enhance the body's immune response against cancer cells. It is classified as an immunotherapy agent.

Investigated diseases

HER2-negative/low metastatic breast cancer – This type of breast cancer is characterized by the absence or low levels of the HER2 protein, which is a growth-promoting protein on the outside of all breast cells. In HER2-negative/low cases, the cancer cells do not have excess HER2 protein, which means they may not respond to treatments that target HER2. This cancer can spread to other parts of the body, a process known as metastasis. The progression of the disease involves the growth and spread of cancer cells beyond the original tumor site. It can affect various organs and tissues, leading to a range of symptoms depending on where the cancer has spread. The disease's behavior and progression can vary widely among individuals.