RecruitingPHASE2INTERVENTIONAL

Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

The FUTURE trial is testing a new approach for people with advanced bowel cancer who haven't had previous treatment. It combines an experimental drug called futibatinib, taken by mouth, with standard chemotherapy and another drug called tislelizumab, given through a drip. Researchers want to see if this combination helps shrink the cancer or stop it from growing. They're also looking closely at the safety of these treatments together and how they might affect patients' quality of life. An important part of the study is to find biological signs (biomarkers) that could help doctors understand who might respond best to this treatment in the future. This study will involve 33 patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

Start

16 Dec 2025

Estimated completion

01 Mar 2028

Colorectal Cancer

What is this study about?

This study, called the FUTURE trial, is designed for people who have advanced bowel (colorectal) cancer that has spread or cannot be removed by surgery. It's for those who haven't received treatment for their advanced cancer yet. The main aim is to see if combining a new medicine called futibatinib with standard chemotherapy and an immunotherapy drug called tislelizumab is an effective and safe way to treat this type of cancer.

Futibatinib is a type of targeted therapy, while tislelizumab is an immunotherapy that helps your body's own immune system fight cancer. The researchers are hoping that by using these medicines together with chemotherapy, they can improve the chances of treating the cancer effectively. They will be carefully watching to see how many people's cancers either shrink or disappear completely.

Beyond just effectiveness, the study will also look at how long the treatment keeps the cancer under control (progression-free survival) and how it affects overall survival. Patient safety is a top priority, so doctors will be monitoring for any side effects. An exciting part of the study is that researchers will also be looking for clues in patients' bodies (called biomarkers) that might tell them who is most likely to benefit from this specific combination of treatments. This could help tailor cancer treatments more precisely in the future.

Key takeaways

It's a study for advanced bowel cancer where you haven't had previous treatment.
Combines standard chemotherapy with new drugs: futibatinib (a pill) and tislelizumab (a drip).
Aims to see how effective and safe this new combination is.
Researchers are also looking for ways to predict who will benefit most from the treatment.
Participation could last up to 12 months.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and have bowel cancer that has spread or cannot be removed by surgery. This must be your first treatment for advanced cancer. You'll need to agree to take part in the study's research, which includes providing samples for scientists to study.

Your general health needs to be good enough to take part. This means your blood tests, liver, and kidney functions must be within certain healthy ranges. You should also be able to carry out your daily activities without too much difficulty. If you are a woman who could become pregnant, or a man with a female partner who could become pregnant, you'll need to agree to use effective birth control throughout the study.

The research team will carry out several checks to make sure the study is right for you and safe for you to join. This includes reviewing your medical history and current health status in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced bowel cancer that has spread or cannot be removed by surgery?
Have I received any treatment for my advanced cancer before?
Am I generally well and able to manage most daily activities?
Are my blood tests, kidney, and liver functions generally healthy?
Am I willing to use effective contraception if I could become pregnant or have a partner who could?
Am I at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of treatments. This includes standard chemotherapy (given through a drip), tislelizumab (also given through a drip), and futibatinib (taken as a pill by mouth once a day, every day). The treatments will typically be given in 6-week cycles. You will receive chemotherapy on days 1, 15, and 29 of each cycle, and tislelizumab on days 1 and 22. Your futibatinib pills will be taken continuously.

You will continue to receive these study treatments for up to 12 months, or until your cancer starts to grow again, you experience side effects that are too difficult to manage, you decide you no longer want to participate, or your doctor feels it's no longer in your best interest. You will have regular appointments and tests to monitor your health and how the treatment is working. This will involve blood tests and scans, and you'll be asked about your quality of life.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new combination of treatments that could be more effective than current standard options for your advanced bowel cancer. However, as with any medical treatment, there are potential risks. You might experience side effects from the chemotherapy, immunotherapy, and the study drug futibatinib. These side effects will be carefully monitored by the medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Klinikum St. Marien Amberg
Verified postcode
Amberg, Germany· Not yet recruiting
Charité Campus Virchow Klinikum (CVK)
Verified postcode
Berlin, Germany· Not yet recruiting
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Kliniken Essen-Mitte
Verified postcode
Essen, Germany· Recruiting
Krankenhaus Nordwest
Verified postcode
Frankfurt am Main, Germany· Recruiting
Hope Hamburg
Verified postcode
Hamburg, Germany· Recruiting
Universitätsmedizin Mainz
Verified postcode
Mainz, Germany· Not yet recruiting
Klinikum München rechts der Isar
Verified postcode
München, Germany· Recruiting
MVZ für Hämatologie und Onkologie Ravensburg GmbH
Verified postcode
Ravensburg, Germany· Not yet recruiting
Leopoldina Krankenhaus Schweinfurt
Verified postcode
Schweinfurt, Germany· Recruiting

Common questions

What type of cancer is this study for?

This study is for people with advanced bowel (colorectal) cancer that has spread or cannot be removed by surgery, and who have not yet received treatment for their advanced cancer.

What drugs will I be taking?

You will receive standard chemotherapy, an immunotherapy called tislelizumab (given through a drip), and a new pill called futibatinib (taken daily by mouth).

How long will the treatment last?

You will receive the study treatment for up to 12 months, or until your cancer worsens, side effects are too severe, or you choose to stop.

What are biomarkers?

Biomarkers are biological clues found in your body that can help doctors understand how your cancer might respond to certain treatments. The study aims to identify these clues.

How many people will be in this study?

This particular part of the study (FUTURE-001) will involve 33 patients.

How to find out more

Thorsten O. Götze, Prof. Dr.

future@ikf-khnw.de 0049 69 7601 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.