RecruitingPHASE2INTERVENTIONAL

MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma

This research study, called TACTIC, is looking at a new way to treat bile duct cancer that has spread or can't be removed by surgery. The study combines a new drug called MP0317 with a standard chemotherapy (gemcitabine and cisplatin) and an immunotherapy drug (durvalumab). Immunotherapy helps your body's immune system fight cancer. Researchers want to find out if this new combination treatment is effective and safe. They are especially interested in seeing how many patients are living without their cancer growing 12 months after starting treatment. The study also aims to understand how our bodies respond to this treatment at a molecular and immune level.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

22 Dec 2025

Estimated completion

01 Nov 2029

Advanced Biliary Tract Carcinoma

What is this study about?

This clinical trial is an important step in finding better treatments for advanced bile duct cancer. Bile duct cancer, also known as cholangiocarcinoma, is a type of cancer that starts in the small tubes that carry bile from the liver. When it's advanced, it means the cancer has spread or can't be treated with surgery.

The study combines several types of treatment. The standard part includes chemotherapy, which uses drugs to kill cancer cells, and immunotherapy (durvalumab), which helps your immune system fight the cancer. The new element is a drug called MP0317. Researchers believe that MP0317 might make the other treatments more effective by targeting specific proteins related to the cancer.

The main goal of this study is to see how many patients treated with this new combination are still free from cancer growth after 12 months. They are also carefully monitoring for any side effects to make sure the treatment is safe. By including a control group and studying different body responses, scientists hope to gain a much clearer understanding of how this new combination works and who might benefit most from it.

Key takeaways

This study tests a new three-drug combination for advanced bile duct cancer.
It combines a new drug (MP0317) with standard chemotherapy and immunotherapy.
The main goal is to see how many patients are cancer-growth-free after 12 months.
75 patients will be involved in this Phase 2 trial.
Researchers will also study how treatments affect the body at a cellular level.

Who may be eligible?

To join this study, you must have bile duct cancer that has either spread or cannot be removed through surgery. Importantly, you should not have received any previous cancer treatment that affects your whole body. However, if you had a preventative chemotherapy called Capecitabine after surgery and finished it at least 6 months ago, you might still be able to join.

Your cancer must be confirmed by a biopsy, and you should be at least 18 years old. Doctors will also check your overall health and how well you can perform daily activities. You will need to be well enough to handle the treatments involved in the study. Your cancer also needs to be measurable, meaning doctors can see and track its size with scans.

Women who could become pregnant must use highly effective birth control and have a negative pregnancy test before starting treatment, and continue using birth control for several months after finishing the medication. This is to protect any potential pregnancy from the effects of the treatment.

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 you have bile duct cancer that has spread or cannot be removed by surgery?
Are you at least 18 years old?
Have you not had any recent overall cancer treatment (like chemotherapy), except for Capecitabine finished over 6 months ago?
Are you generally well and active enough for daily tasks?
If you are a woman who could become pregnant, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the requirements. If you qualify, you'll be assigned to one of two groups by chance – like flipping a coin. One group will receive the new drug MP0317 along with standard chemotherapy and immunotherapy, while the other group will receive just the standard chemotherapy and immunotherapy.

The study will involve regular visits to the clinic for treatments, blood tests, and scans (like CT scans) to monitor your health and how your cancer is responding. The doctors and nurses will carefully check for any side effects and adjust your care as needed. The total duration of your participation in the treatment phase will depend on how you respond to the medication, but you will be followed up by the research team for some time after your treatment finishes to monitor your long-term health.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new and potentially more effective combination treatment for your cancer that isn't available outside of a clinical trial. However, there are also potential risks involved, as all treatments can have side effects. The study team will closely monitor you for any side effects, which can range from mild to more serious, and will provide care and support. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

CHU de Besançon
Verified postcode
Besançon, France· Recruiting
Centre georges-François Leclerc
Verified postcode
Dijon, France· Recruiting
CHU de Grenoble
Verified postcode
Grenoble, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
Hôpital Beaujon
Verified postcode
Paris, France· Recruiting
Hôpital La Pitié-Salpétrière
Verified postcode
Paris, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
Centre Eugène Marquis
Verified postcode
Rennes, France· Recruiting
CHU de Tours
Verified postcode
Tours, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Not yet recruiting

Common questions

What is bile duct cancer?

Bile duct cancer, or cholangiocarcinoma, is a cancer that starts in the tubes that carry bile from your liver to your small intestine.

What does 'unresectable' mean?

'Unresectable' means the cancer cannot be completely removed by surgery, often because it has grown too large or spread too much.

What is the new drug, MP0317, supposed to do?

MP0317 is a new drug called a 'CD40 agonist' that aims to boost the body's immune response to fight cancer, potentially making other treatments more effective.

Will I know which treatment group I'm in?

Because this is a 'randomised' study, you will be assigned to a treatment group by chance. You won't be able to choose your group, and sometimes you might not know which specific group you're in (this is called 'blinding').

How long will I be in the study?

The treatment part of the study can vary, but regular monitoring and follow-up will continue for a period after treatment ends to track your long-term health.

How to find out more

Christophe BORG, Pr

xtoph.borg@gmail.com 00 33 3 70 63 22 19 Official trial record

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