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Study of MP0317 with durvalumab, gemcitabine and cisplatin combination therapy as first-line treatment for patients with advanced biliary tract cancer

Verified siteRegistered drugNo 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 focuses on treating patients with Advanced Biliary Tract Carcinoma, a type of cancer that affects the bile ducts. The study evaluates a new treatment approach combining several medications: MP0317 (an experimental drug), durvalumab (an immunotherapy medication), and two chemotherapy drugs - gemcitabine and cisplatin.

The purpose of this study is to determine how well this combination therapy works in patients who have not previously received treatment for their advanced bile duct cancer. The treatment involves giving the medications through intravenous infusions, which means they are delivered directly into the bloodstream through a vein.

During the study, patients will receive treatment over several months. The doctors will monitor how the cancer responds to the treatment using imaging scans. They will also track any side effects that may occur and evaluate how the treatment affects patients' quality of life. The study will measure how long patients live without their cancer getting worse and their overall survival time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment cycle begins

    The treatment consists of four medications administered through intravenous infusion: gemcitabine, durvalumab, cisplatin, and MP0317

    Treatment will be provided to patients with advanced biliary tract carcinoma (cancer of the bile ducts)

  2. Step 2

    Regular monitoring and assessments

    Regular medical examinations will be conducted to monitor the response to treatment

    Doctors will assess the condition using RECIST criteria (a standardized way to measure if tumors are responding to treatment)

    Blood samples will be collected to monitor treatment effectiveness

    Quality of life assessments will be conducted using specialized questionnaires (EORTC-QLQ-C30 and EORTC QLQ-BIL21)

  3. Step 3

    Ongoing treatment and evaluation

    Treatment will continue while monitoring for any side effects

    Side effects will be assessed using standardized criteria

    Regular imaging scans will be performed to evaluate tumor response

    Blood tests will check for antibodies and medication levels in the body

  4. Step 4

    12-month assessment

    A major evaluation will occur at the 12-month mark to assess if the disease has progressed

    Doctors will determine the effectiveness of the treatment based on tumor measurements

    The assessment will include evaluation of overall health status and quality of life

  5. Step 5

    Long-term follow-up

    Continued monitoring until November 2028 (estimated study end date)

    Regular assessments of survival and disease status

    Ongoing evaluation of long-term treatment effects

Who can join the trial?

13 criteria

  • Must sign and date an informed consent form
  • Must complete hepatitis B and C screening tests
  • Must be covered by French social security system
  • Must be able to follow study requirements as determined by the doctor
  • Must have confirmed biliary tract cancer (cancer in the bile ducts inside or outside the liver, excluding gallbladder cancer)
  • Must have advanced cancer that has spread or cannot be surgically removed
  • Must not have received previous cancer treatments (except Capecitabine treatment that ended at least 6 months ago)
  • Must be at least 18 years old
  • Must have cancer that can be measured using special imaging techniques
  • If previously received radiation therapy, must have recovered from side effects to mild or no symptoms
  • Must have good physical function ability (ECOG performance score less than 2, meaning able to carry out most daily activities)
  • Female participants must either:
    • Use effective birth control and have a negative pregnancy test before starting treatment, or
    • Be unable to become pregnant

Who cannot join the trial?

12 criteria

  • Prior treatment with systemic anti-cancer therapy for advanced biliary tract cancer
  • Known brain metastases (spread of cancer to the brain) that are untreated or unstable
  • Active or prior autoimmune disease (condition where immune system attacks healthy cells) within the past 2 years
  • History of other cancers within 3 years before starting the study, except for successfully treated non-melanoma skin cancer or cervical cancer
  • Significant heart problems including uncontrolled high blood pressure, heart attack within 6 months, or irregular heartbeat
  • Active or chronic hepatitis B or C (liver infections)
  • Active tuberculosis (TB) infection
  • Pregnant or breastfeeding women
  • Known allergic reactions to the study medications or their components
  • Participation in another clinical trial within 4 weeks before starting this study
  • Major surgery within 4 weeks before starting the study
  • Any condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial
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Investigated drugs

Based on the trial information provided, the medications involved are: MP0317 is a novel targeted therapy designed to activate CD40 receptors specifically in tumor areas where FAP (Fibroblast Activation Protein) is present. It's a DARPin molecule that aims to stimulate the immune system's response against cancer cells while minimizing side effects in healthy tissues. Durvalumab is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein called PD-L1, which can help the immune system recognize and attack cancer cells more effectively. Gemcitabine is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell growth and division, helping to stop or slow the spread of cancer cells. Cisplatin is a platinum-based chemotherapy medication that damages the DNA of cancer cells, preventing them from dividing and growing. It's commonly used in combination with other cancer treatments to increase their effectiveness.

What is already known about the treatment

  • MP0317

    A novel investigational FAP-dependent CD40 agonist DARPin molecule designed for targeted cancer therapy, administered intravenously in combination with other cancer treatments. This experimental drug is currently being studied in clinical trials for advanced biliary tract carcinoma, working by selectively targeting fibroblast activation protein (FAP) in the tumor microenvironment and activating CD40-mediated immune responses. It belongs to the class of immunotherapeutic agents and is being evaluated in combination with durvalumab and standard chemotherapy (gemcitabine/cisplatin) as a first-line treatment strategy.

  • Durvalumab

    A human monoclonal antibody administered through intravenous infusion that blocks the PD-L1 protein, enhancing the immune system's ability to fight cancer cells. Currently approved for various cancer types and being studied in biliary tract carcinoma, this medication works by preventing cancer cells from evading immune system detection. It belongs to the class of immune checkpoint inhibitors and is being tested in combination with MP0317 and standard chemotherapy for improved treatment outcomes.

  • Gemcitabine

    An established chemotherapy medication administered intravenously that works by interfering with cancer cell DNA replication and growth. This medication is widely used in various cancer treatments, including biliary tract cancer, and functions by replacing one of the building blocks of cellular DNA, causing cancer cell death. It belongs to the antimetabolite class of chemotherapy drugs and is considered a standard treatment option in combination with cisplatin.

  • Cisplatin

    A platinum-based chemotherapy drug given through intravenous infusion that works by damaging cancer cell DNA and preventing cell division. This well-established medication has been used in cancer treatment for decades and forms cross-links in DNA strands, leading to cancer cell death. It belongs to the platinum-containing compounds class and is commonly used in combination with gemcitabine as standard therapy for biliary tract cancer.

Investigated diseases

Biliary Tract Carcinoma - A cancer that develops in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine. The disease begins in the cells that line these ducts and can occur in any part of the biliary system. As the cancer grows, it can block the bile ducts and spread to nearby organs. The condition typically develops gradually, with the tumor growing and potentially spreading to other parts of the biliary system. Advanced biliary tract carcinoma refers to the stage where the cancer has grown beyond its original location.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520029-35-01Protocol code2024/926Estimated enrolment75 patientsSponsorCentre Hospitalier Regional Universitaire

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