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Study of Trastuzumab Deruxtecan and Rilvegostomig for Patients with Advanced HER2-positive Biliary Tract 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 a type of cancer known as HER2-expressing Biliary Tract Cancer, which affects the bile ducts. The study will compare the effectiveness of a new treatment combination against the current standard treatment. The new treatment involves two medications: Trastuzumab Deruxtecan (also known as DS-8201a) and Rilvegostomig (also known as AZD2936). Trastuzumab Deruxtecan is a type of medication called an antibody-drug conjugate, which is designed to target and kill cancer cells. Rilvegostomig is a bispecific monoclonal antibody that targets specific proteins involved in cancer growth. The standard treatment being compared includes the medications Gemcitabine, Cisplatin, and Durvalumab.

The purpose of this study is to see if the new treatment combination can improve the overall survival of patients with this type of cancer compared to the standard treatment. Participants in the study will be randomly assigned to receive either the new treatment or the standard treatment. The study will monitor the participants over time to assess the effectiveness and safety of the treatments. The study will also look at other factors such as how long the treatments can keep the cancer from getting worse and the overall response of the cancer to the treatments.

This study is important because it aims to find better treatment options for patients with advanced biliary tract cancer, which is a challenging condition to treat. By participating in this study, researchers hope to gather valuable information that could lead to improved outcomes for patients in the future. The study is expected to continue for several years to ensure comprehensive data collection and analysis.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A sample of the tumor, no older than three years, is required for analysis. This helps in confirming the presence of HER2-expressing biliary tract cancer.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups. One group receives the investigational treatment, and the other receives the standard treatment.

    The investigational treatment includes trastuzumab deruxtecan (T-DXd) and rilvegostomig. The standard treatment includes gemcitabine, cisplatin, and durvalumab.

  3. Step 3

    Treatment administration

    For those receiving the investigational treatment, trastuzumab deruxtecan and rilvegostomig are administered through an intravenous infusion. The frequency and dosage are determined by the study protocol.

    For those receiving the standard treatment, gemcitabine, cisplatin, and durvalumab are also administered intravenously. The specific schedule and dosage are outlined in the study protocol.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring is conducted to assess health status and response to treatment. This includes physical exams, blood tests, and imaging studies.

    Participants are required to report any side effects or changes in health to the study team promptly.

  5. Step 5

    Follow-up visits

    After completing the treatment phase, follow-up visits are scheduled to monitor long-term health and any potential late effects of the treatment.

    These visits may include additional tests and assessments as determined by the study protocol.

Who can join the trial?

8 criteria

  • Participants must be 18 years or older at the time of screening. There may be other age restrictions based on local rules.
  • Participants must have unresectable (cannot be removed by surgery), previously untreated, locally advanced or metastatic biliary tract cancer (BTC). If they had treatment around the time of surgery or after surgery, it is allowed if more than 6 months have passed between the end of that treatment and the diagnosis of advanced disease.
  • The cancer must be confirmed to be HER2-expressing (a specific protein found in some cancer cells) with a score of IHC 3+ or IHC 2+.
  • Participants must provide a tumor sample that is no older than 3 years.
  • There must be at least one target lesion (a specific area of cancer) that can be measured by the study doctor using a standard method called RECIST v1.1.
  • Participants must have a WHO/ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • Participants must have adequate organ and bone marrow function within 14 days before being randomly assigned to a treatment group.
  • Females who can have children must show evidence of being post-menopausal (no longer having menstrual periods) or have a negative blood pregnancy test.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer that is not HER2-expressing Biliary Tract Cancer cannot participate. HER2 is a protein that can affect the growth of cancer cells.
  • Patients who have received certain treatments for cancer that are not part of the study may be excluded.
  • Patients with serious heart conditions or diseases affecting the heart may not be eligible.
  • Patients with uncontrolled infections or illnesses that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study drugs or similar drugs may be excluded.
  • Patients with severe liver or kidney problems may not be eligible.
  • Patients who are unable to follow the study procedures or attend study visits may be excluded.
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Investigated drugs

  • Trastuzumab Deruxtecan (T-DXd)

    is a medication used in this trial to treat biliary tract cancer. It is a type of targeted therapy that works by attaching to a specific protein called HER2 on the surface of cancer cells. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cell, which helps to kill the cancer cells and stop them from growing.

  • Rilvegostomig

    is another medication being tested in this trial. It is designed to work alongside Trastuzumab Deruxtecan to enhance its effects. Rilvegostomig helps to boost the immune system's ability to fight cancer by targeting specific pathways that cancer cells use to grow and spread.

  • Gemcitabine

    is a chemotherapy drug that is part of the standard treatment for biliary tract cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. This helps to slow down or stop the progression of the cancer.

  • Cisplatin

    is another chemotherapy medication used in the standard treatment. It works by damaging the DNA in cancer cells, which prevents them from multiplying. This can help to shrink tumors and slow the spread of cancer.

  • Durvalumab

    is an immunotherapy drug that is part of the standard treatment. It helps the immune system recognize and attack cancer cells more effectively. By blocking a specific protein that cancer cells use to hide from the immune system, Durvalumab allows the body's natural defenses to better target and destroy the cancer.

What is already known about the treatment

  • Trastuzumab Deruxtecan (T-DXd)

    This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced HER2-expressing biliary tract cancer. The main therapeutic use of T-DXd is to target and destroy cancer cells that express the HER2 protein. At the molecular level, it works by binding to the HER2 protein on cancer cells and delivering a toxic drug directly to them, which helps to kill the cancer cells. T-DXd is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

  • Rilvegostomig

    This medication is also administered intravenously and is being investigated in clinical trials alongside T-DXd for the treatment of advanced HER2-expressing biliary tract cancer. Its primary therapeutic role is to enhance the effectiveness of cancer treatment by targeting specific pathways involved in cancer cell growth. The exact mechanism of action at the molecular level is still under study, but it is believed to work by interfering with signals that promote cancer cell survival. Rilvegostomig is classified as a monoclonal antibody, which is a type of targeted therapy designed to recognize and bind to specific proteins on cancer cells.

Investigated diseases

Advanced HER2-expressing Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts, which are part of the digestive system. It is characterized by the overexpression of the HER2 protein, which can promote the growth of cancer cells. The disease typically progresses as the cancer cells grow and spread within the bile ducts and potentially to other parts of the body. As the cancer advances, it can cause blockages in the bile ducts, leading to symptoms such as jaundice, abdominal pain, and digestive issues. The progression of the disease can vary, with some cases advancing more rapidly than others. The focus of research is often on understanding how the HER2 protein contributes to the disease's progression and finding ways to target it effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508057-19-00Protocol codeD781PC00001Estimated enrolment338 patientsSponsorAstraZeneca AB

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