Not recruiting

Study on the Effects of Ezabenlimab and BI 907828 in Adult Patients with Advanced or Metastatic Solid Tumors

Verified siteInvestigationalNo 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 combination of two treatments, Ezabenlimab and BI 907828, on certain types of cancer. The study involves adult patients with advanced or spreading solid tumors, specifically targeting two groups: one with soft-tissue sarcoma and another with various solid tumors such as non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), microsatellite stable colorectal cancer (MSS-CCR), and biliary tract cancer (BTC). The purpose of the study is to explore how well these treatments can control the disease.

Ezabenlimab is a type of medication known as a monoclonal antibody, which is given through an infusion into a vein. It works by targeting a protein called PD-1, which can help the immune system fight cancer. BI 907828 is a tablet taken by mouth and is designed to block a protein interaction that can lead to cancer growth. The study will assess the effectiveness of these treatments in controlling the disease, which means looking at whether the cancer stops growing, shrinks, or disappears for a period of time.

Participants in the study will receive either the combination of Ezabenlimab and BI 907828 or a placebo. The study will last for a period of up to 156 weeks, during which the health and response of the participants will be closely monitored. The goal is to determine if the combination of these treatments can provide better control of the cancer compared to existing treatments. The study will also look at the safety and any side effects of the treatment combination.

The research process

The trial runs in 5 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, a confirmation of diagnosis is required. This includes a review or confirmation by a specialized network for certain types of cancer.
A negative pregnancy test is necessary for women of childbearing potential before starting the treatment.
Participants must agree to use two methods of contraception during the study and for a specified period after the treatment ends.
Step 2
Initial assessment
An initial assessment will be conducted to ensure eligibility, including a review of medical history and current health status.
Participants must have measurable disease as defined by specific criteria.
Step 3
Treatment phase
The treatment involves two medications: Ezabenlimab and BI 907828.
Ezabenlimab is administered as an intravenous infusion. The frequency and duration of administration will be determined by the study protocol.
BI 907828 is provided in the form of film-coated tablets for oral use. The dosage and frequency will be specified in the study protocol.
Step 4
Monitoring and follow-up
Regular monitoring will occur to assess the response to treatment and any side effects. This includes radiological assessments and other tests as needed.
Participants will be monitored for disease control, which includes stable disease or response to treatment lasting at least 24 weeks.
Step 5
End of treatment
The study is expected to continue until September 2027, with individual participation duration varying based on response and health status.
After completing the treatment phase, follow-up assessments will be conducted to evaluate long-term outcomes and any delayed side effects.

Who can join the trial?

16 criteria

Must be an adult aged 18 years or older.
Must have advanced or metastatic disease, meaning the cancer has spread to other parts of the body.
Must have a confirmed diagnosis of specific types of cancer, such as soft-tissue sarcoma, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer, or biliary tract cancer.
Must have a life expectancy of at least 8 weeks.
Must have adequate blood and organ function, which includes specific levels of blood cells and liver enzymes.
Must have experienced disease progression on previous treatments or have a disease with no available acceptable treatment.
Must have recovered from any side effects of previous treatments to a certain level, except for hair loss and mild skin changes.
Must be able to follow the study protocol, as judged by the study doctor.
Women who can have children must have a negative pregnancy test before starting the study treatment and agree to use two forms of birth control during the study and for a specified time after.
Men must also agree to use two forms of birth control during the study and for a specified time after.
Must not have had any other cancer diagnosed or treated in the last 2 years, except for certain types of skin cancer or bladder cancer that have been treated successfully.
Must sign a written informed consent form before any study-specific procedures.
Must have social security in compliance with French law.
Must have a specific tumor status known, such as TP53-wild type or MDM2 status, depending on the cancer type.
Must have measurable disease, meaning there is a tumor that can be measured using a CT scan.
Must have a performance status of 0-2, which indicates the ability to carry out daily activities.

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Verified sites

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

Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Universitaire De Dijon
Verified
Dijon, France
Centre Hospitalier Universitaire De Poitiers
Verified
Poitiers, France

Trial locations

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Investigated drugs

Ezabenlimab
is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. By inhibiting this protein, ezabenlimab may enhance the body's ability to detect and destroy cancer cells.
BI 907828
is another medication involved in the trial. It targets a protein called MDM2, which is often overactive in cancer cells. By inhibiting MDM2, BI 907828 can help to restore the normal function of a protein called p53, which plays a crucial role in controlling cell growth and death. This action may lead to the reduction of tumor growth and potentially shrink the tumors.

What is already known about the treatment

Ezabenlimab
This medication is administered intravenously and is currently being studied in clinical trials for its potential to treat adult patients with locally advanced or metastatic solid tumors. It is primarily being investigated for its effectiveness in soft-tissue sarcoma, non-small cell lung cancer, triple-negative breast cancer, MSS colorectal cancer, and biliary tract cancer. Ezabenlimab works by targeting the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.
BI 907828
This medication is taken orally and is also under investigation in clinical trials for treating adult patients with locally advanced or metastatic solid tumors. It is being studied for its potential use in soft-tissue sarcoma and various solid tumors, including non-small cell lung cancer, triple-negative breast cancer, MSS colorectal cancer, and biliary tract cancer. BI 907828 functions by inhibiting the MDM2 protein, which can lead to the activation of tumor suppressor pathways and promote cancer cell death. It is classified as an MDM2 inhibitor.

Investigated diseases

Soft Tissue Sarcoma
Soft tissue sarcoma is a type of cancer that begins in the soft tissues of the body, such as muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. It can occur anywhere in the body but is most commonly found in the arms, legs, and abdomen. The disease often starts as a painless lump or swelling and may grow slowly or rapidly. As it progresses, it can cause pain or interfere with normal body functions, depending on its location. Soft tissue sarcomas are a diverse group of cancers, with many different subtypes, each with its own characteristics. The progression and behavior of the disease can vary significantly based on the specific type and location of the sarcoma.
Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease often develops slowly and may not cause symptoms until it is advanced. Common symptoms include a persistent cough, chest pain, and shortness of breath. NSCLC is categorized into several subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, each with distinct characteristics. The progression of NSCLC can vary, with some tumors growing slowly and others spreading more quickly.
Triple Negative Breast Cancer (TNBC)
Triple negative breast cancer is a type of breast cancer that lacks the three most common types of receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This makes it more challenging to treat, as hormone therapies and drugs that target HER-2 are ineffective. TNBC tends to be more aggressive and is more likely to spread and recur than other types of breast cancer. It often affects younger women and is more common in women with a BRCA1 gene mutation. The disease typically presents as a lump in the breast and may progress rapidly, requiring prompt medical attention.
Microsatellite Stable Colorectal Cancer (MSS-CRC)
Microsatellite stable colorectal cancer is a subtype of colorectal cancer characterized by the absence of microsatellite instability, a condition of genetic hypermutability. This type of cancer is more common than its counterpart, microsatellite instability-high (MSI-H) colorectal cancer. MSS-CRC usually follows a more traditional pathway of cancer development, often associated with chromosomal instability. It can start as a benign polyp in the colon or rectum and gradually progress to cancer over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of MSS-CRC can vary, with some cases remaining localized while others may spread to distant organs.
Biliary Tract Cancer (BTC)
Biliary tract cancer is a group of cancers that occur in the bile ducts, gallbladder, or ampulla of Vater. These cancers are relatively rare and can be challenging to diagnose early due to their location and nonspecific symptoms. BTC often presents with symptoms such as jaundice, abdominal pain, and weight loss. The disease can progress by invading nearby structures or spreading to distant organs. Biliary tract cancers are classified based on their location, including intrahepatic, perihilar, and distal bile duct cancers, each with unique characteristics. The progression and behavior of BTC can vary, with some tumors growing slowly and others spreading more aggressively.