Not recruiting

Study on Botensilimab Alone and with Balstilimab or Drug Combination for Patients with Refractory Metastatic Colorectal 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 treatments for Refractory Metastatic Colorectal Cancer, a type of cancer that has spread to other parts of the body and does not respond to standard treatments. The study will explore the effectiveness of a new treatment called Botensilimab (also known as AGEN1181) both on its own and in combination with another treatment called Balstilimab (also known as AGEN2034). Additionally, the study will compare these treatments to the standard care options, which include Regorafenib and a combination of Trifluridine and Tipiracil.

The purpose of the study is to evaluate how well these treatments work in patients with this type of cancer. Participants in the study will be randomly assigned to receive either Botensilimab alone, Botensilimab with Balstilimab, or one of the standard care treatments. The study will monitor the participants over a period of time to see how their cancer responds to the treatment they receive. This will help researchers understand which treatment options might be most effective for patients with this challenging form of cancer.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the progress of their cancer. The study aims to provide valuable information that could lead to better treatment options for people with Refractory Metastatic Colorectal Cancer in the future. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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
Initial visit
Upon joining the study, you will have an initial visit where you will meet with the study team. During this visit, your medical history will be reviewed, and you will undergo a physical examination.
You will also have blood tests and imaging studies to assess your current health status and the extent of your condition.
Step 2
Randomization
After the initial assessments, you will be randomly assigned to one of the treatment groups. This means you will receive either botensilimab alone, botensilimab with balstilimab, or a standard treatment chosen by the investigator, which could be regorafenib or trifluridine and tipiracil.
Step 3
Treatment administration
If you are assigned to receive botensilimab, it will be given as an intravenous infusion. If you are in the combination group, you will also receive balstilimab as an infusion.
If you are in the standard treatment group, you will take regorafenib or trifluridine and tipiracil orally in the form of film-coated tablets. The dosage and frequency will be explained to you by the study team.
Step 4
Regular follow-up visits
You will have regular follow-up visits to monitor your response to the treatment and any side effects. These visits will include physical exams, blood tests, and imaging studies.
The frequency of these visits will be determined by the study protocol and your specific treatment plan.
Step 5
End of treatment
Once you complete the treatment phase, you will have a final evaluation to assess your overall response to the treatment.
This evaluation will include a physical exam, blood tests, and imaging studies to determine the effectiveness of the treatment.
Step 6
Long-term follow-up
After the treatment phase, you may be asked to participate in long-term follow-up visits. These visits are designed to monitor your health and any long-term effects of the treatment.
The study team will provide you with a schedule for these follow-up visits.

Who can join the trial?

14 criteria

Must have a confirmed diagnosis of colorectal cancer that cannot be removed by surgery and has spread to other parts of the body.
Must have had at least one previous chemotherapy treatment for colorectal cancer that has spread or come back.
Must be 18 years of age or older.
Must have a life expectancy of at least 12 weeks.
Must have a performance status of 0 or 1 on the ECOG scale, which measures daily living abilities.
Must have adequate organ function, which will be checked by blood tests.
Must have measurable disease based on imaging tests.
Must not have received growth factor support, transfusions, or albumin administration within 14 days before starting the study treatment.
Must provide a recent tumor sample, or be willing to provide a new biopsy if needed.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for a period after the study ends.
Men with partners who can have children must agree to use effective birth control during the study and for a period after the study ends.
Must be willing and able to follow the study requirements.
Must have had the tumor tested for specific genetic markers called MSI-H or dMMR.
Must voluntarily agree to participate by signing a consent form.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than **refractory metastatic colorectal cancer**. This means the cancer has spread and does not respond to treatment.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have had a recent major surgery.
Patients who have an active infection that requires treatment.
Patients who have a history of certain heart conditions.

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Verified sites

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

ASST Grande Ospedale Metropolitano Niguarda
Verified
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Botensilimab (AGEN1181)
is a medication being studied for its potential to treat metastatic colorectal cancer that has not responded to other treatments. It is being tested both on its own and in combination with another medication. The goal is to see if it can help shrink tumors or stop them from growing.
Balstilimab (AGEN2034)
is another medication involved in this study. It is used in combination with Botensilimab to see if the two drugs together can be more effective in treating colorectal cancer. This combination aims to enhance the body's immune response against cancer cells.
Regorafenib
is a standard treatment option for colorectal cancer. It works by blocking certain proteins that cancer cells need to grow. In this study, it is used as a comparison to see how well the new treatments perform against an established therapy.
Trifluridine and Tipiracil
is another standard treatment for colorectal cancer. This combination works by interfering with the DNA of cancer cells, which can help to slow down or stop their growth. Like Regorafenib, it is used in the study to compare the effectiveness of the new treatments.

What is already known about the treatment

Botensilimab
Botensilimab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating refractory metastatic colorectal cancer. It is being tested both as a standalone treatment and in combination with another medication called balstilimab. Botensilimab works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells more effectively. It is classified as an immunotherapy drug, which means it helps boost the body's natural defenses to fight cancer.
Balstilimab
Balstilimab is given as an injection and is under investigation in clinical trials for its potential to treat refractory metastatic colorectal cancer, particularly in combination with botensilimab. This medication functions by blocking certain proteins that usually help cancer cells evade the immune system, thereby enhancing the body's ability to fight the cancer. Balstilimab is also classified as an immunotherapy drug, focusing on strengthening the immune response against cancer cells.

Investigated diseases

Refractory Metastatic Colorectal Cancer – This disease is a type of colorectal cancer that has spread to other parts of the body and does not respond to standard treatments. It originates in the colon or rectum and can metastasize to organs such as the liver, lungs, or lymph nodes. The cancer cells continue to grow and divide uncontrollably, forming tumors in new locations. As the disease progresses, it can cause symptoms like abdominal pain, changes in bowel habits, and weight loss. The spread of cancer to other organs can lead to additional complications, depending on the affected areas. The progression of the disease is marked by the continued growth and spread of cancer cells despite treatment efforts.