Recruiting

Study on the Safety and Effectiveness of OMTX705 with Regorafenib and Tislelizumab for Patients with Advanced 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 advanced or metastatic colorectal cancer, which is a type of cancer that affects the colon or rectum and has spread to other parts of the body. The study will explore the use of a new treatment called OMTX705, which is an antibody-drug designed to target specific proteins in cancer cells. This treatment will be tested in combination with two other medications: regorafenib, a drug that helps slow the growth of cancer cells, and tislelizumab, an immune therapy that helps the body's immune system fight cancer.

The purpose of the study is to understand the safety and effectiveness of these combinations in patients who have already tried other standard treatments for their cancer. The study will be conducted in two parts. In the first part, researchers will determine the safest dose of OMTX705 when used with regorafenib and with both regorafenib and tislelizumab. In the second part, the study will evaluate how well these combinations work in controlling the cancer. Some patients will receive regorafenib alone to compare the results.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein, and in the case of regorafenib, as oral tablets. The study will monitor the participants' health, including any side effects and changes in their cancer, over a period of time. The goal is to find out if these new combinations can provide a better treatment option for people with advanced colorectal cancer.

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
Initial treatment phase
Upon joining the study, you will begin the initial treatment phase. This involves receiving a combination of medications designed to treat advanced or metastatic colorectal cancer.
You will receive OMTX705 through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.
You will also take regorafenib in the form of oral tablets. The dosage and frequency will be determined by the study team based on your specific needs.
In some cases, you may also receive tislelizumab through an intravenous infusion, depending on the specific part of the study you are in.
Step 2
Monitoring and assessment
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the safety and effectiveness of the medications.
You will undergo various imaging tests, such as CT scans or MRIs, to evaluate the progress of the treatment on your cancer.
Blood tests will be conducted to monitor your overall health and to measure the levels of the medications in your system.
Step 3
Dose adjustment
Based on the results of your assessments, the study team may adjust the dosage of your medications to ensure the best possible outcome.
The goal is to find the maximum tolerated dose that provides the most benefit with the least side effects.
Step 4
Ongoing treatment
You will continue to receive the treatment combination as long as it is deemed beneficial and safe for you.
Regular follow-up appointments will be scheduled to monitor your condition and make any necessary adjustments to your treatment plan.
Step 5
End of trial
The trial is expected to continue until February 2027. Your participation may end earlier if the treatment is no longer effective or if you experience significant side effects.
At the end of your participation, you will have a final assessment to evaluate your overall health and the impact of the treatment.

Who can join the trial?

13 criteria

Must be able to give signed informed consent, which means you understand the study and agree to participate.
Women who can have children and men with partners who can have children must agree to use birth control.
Must have suitable veins for safe drug administration and necessary blood tests.
Must provide a valid tumor sample from a previous biopsy.
For Part 2 of the study, must provide a fresh tumor sample before and during treatment, unless waived by the study doctor.
Must be 18 years or older.
Must have cancer that has worsened after the last treatment or need a change in treatment, as decided by the study doctor.
Must have a confirmed diagnosis of colon or rectal cancer that has spread, and have tried all standard treatments available, unless you couldn't tolerate them.
Must have cancer that is microsatellite stable (MSS), meaning the cancer cells have stable DNA.
Must know the status of specific genes called RAS and BRAF, which are important for treatment decisions.
Must have measurable disease, meaning the cancer can be measured using scans like CT, PET/CT, or MRI.
Must have a good performance status, meaning you are fully active or can carry out light work.
Must have adequate function of bone marrow, liver, and kidneys, which will be checked by blood tests.

Who cannot join the trial?

6 criteria

Patients who have not progressed to at least the second-line of standard systemic therapy for metastatic disease cannot participate.
Patients with medical conditions other than advanced or metastatic colorectal cancer are excluded.
Patients who are not within the specified age range for the study are not eligible.
Patients who are part of a vulnerable population, which means they might be at a higher risk of harm or exploitation, are not eligible.
Patients who are not able to comply with the study procedures or follow-up requirements are excluded.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are not eligible.

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Verified sites

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

Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario De Navarra
Verified
Pamplona, Spain

Trial locations

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Investigated drugs

OMTX705
is a special type of treatment called an antibody-drug conjugate. This means it combines an antibody, which can specifically target certain cells in the body, with a drug that can kill those cells. In this trial, OMTX705 is being tested to see if it can help treat advanced or metastatic colorectal cancer by targeting and destroying cancer cells more effectively.
Regorafenib
is a medication that works by blocking certain proteins that help cancer cells grow and spread. It is used in this trial to see if it can help slow down or stop the growth of colorectal cancer when used alone or in combination with other treatments.
Tislelizumab
is a type of immunotherapy. It helps the body's immune system recognize and attack cancer cells. In this trial, it is being tested to see if it can enhance the body's ability to fight colorectal cancer when used together with other treatments.

What is already known about the treatment

OMTX705
OMTX705 is administered as an injection and is currently being studied in clinical trials for its potential use in treating advanced or metastatic colorectal cancer. It is an antibody-drug conjugate that targets fibroblast activation protein, which is often found in cancerous tissues. By binding to this protein, OMTX705 delivers a toxic payload directly to the cancer cells, aiming to reduce tumor growth. It is being tested in combination with other drugs to assess its safety and effectiveness.
Regorafenib
Regorafenib is taken orally in pill form and is already approved for use in treating certain types of cancer, including colorectal cancer. It works by blocking specific proteins that promote cancer cell growth and blood vessel formation in tumors. This helps to slow down or stop the progression of the disease. In the current trial, it is being used in combination with other medications to explore enhanced treatment effects.
Tislelizumab
Tislelizumab is administered through an intravenous infusion and is being investigated for its role in treating advanced or metastatic colorectal cancer. It is an immune checkpoint inhibitor that helps the body's immune system recognize and attack cancer cells more effectively. By blocking the PD-1 protein on immune cells, tislelizumab enhances the immune response against tumors. It is being tested in combination with other drugs to determine its safety and potential benefits in cancer therapy.

Investigated diseases

Advanced/metastatic colorectal cancer – This disease is a form of colorectal cancer that has spread beyond the colon or rectum to other parts of the body. It typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and organs, and eventually spread to distant sites such as the liver, lungs, or lymph nodes. The progression of the disease is marked by the growth and spread of cancer cells, which can lead to symptoms such as changes in bowel habits, abdominal pain, and weight loss. The disease is often categorized by its stage, with advanced or metastatic stages indicating a more widespread distribution of cancer cells. The progression can vary greatly among individuals, influenced by factors such as the cancer's genetic characteristics and the patient's overall health.