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Study on Zanidatamab with Cisplatin and Gemcitabine for Advanced HER2 Positive Biliary Tract Cancer Patients

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 is focused on studying a type of cancer known as Biliary Tract Cancer (BTC), which affects the bile ducts, gallbladder, and other parts of the biliary system. The trial is specifically looking at cases where the cancer is advanced and has a characteristic called HER2-positive. This means that the cancer cells have more of a protein called HER2 on their surface, which can make the cancer grow more quickly. The study will test a new treatment combination that includes a drug called zanidatamab, which is being tested under the code name JZP598. This drug will be used alongside standard treatments, which include cisplatin and gemcitabine, and may also include drugs that target the immune system, such as durvalumab or pembrolizumab.

The purpose of the study is to compare the effectiveness of the new treatment combination with the standard treatment alone. Participants in the study will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will follow participants over a period of time to see how well the cancer responds to the treatment and to monitor any side effects. The trial will also look at how long participants live without the cancer getting worse and their overall survival.

Participants will be randomly assigned to receive either the new treatment combination or the standard treatment. The study will involve regular visits to the clinic for treatment and monitoring. The trial aims to provide more information about the potential benefits and risks of adding zanidatamab to the current treatment options for advanced HER2-positive biliary tract cancer. This research could help improve future treatment strategies for this type of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatment options being tested.

  2. Step 2

    Treatment administration

    Participants will receive a combination of medications through intravenous administration. The medications include gemcitabine, cisplatin, and zanidatamab. In some cases, a PD-1/L1 inhibitor such as durvalumab or pembrolizumab may also be administered.

    The specific dosage and frequency of each medication will be determined by the study protocol and the participant's health status. The treatment will be administered in cycles, with each cycle lasting a few weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess their response to the treatment. This includes medical examinations, blood tests, and imaging studies to evaluate the progression of the cancer.

    Participants will also be asked to report any side effects or changes in their health status. This information is crucial for understanding the safety and effectiveness of the treatment.

  4. Step 4

    Follow-up

    After completing the treatment cycles, participants will enter a follow-up phase. During this time, their health will continue to be monitored to assess long-term outcomes and any delayed side effects.

    The follow-up phase is an important part of the study, as it provides additional data on the treatment's impact over time.

Who can join the trial?

17 criteria

  • The patient must have a confirmed diagnosis of **biliary tract cancer (BTC)**, which includes types like gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), or extrahepatic cholangiocarcinoma (ECC).
  • The cancer must be **locally advanced** (spread in the area) or **metastatic** (spread to other parts of the body) and cannot be treated with surgery, transplantation, or other local treatments aimed at curing the disease.
  • The patient should not have received more than 2 cycles of specific chemotherapy treatments, which include gemcitabine and cisplatin, with or without certain immune therapy drugs (PD-1/L1 inhibitors).
  • The cancer must be **HER2-positive**, which means it has a specific protein that can be targeted by certain treatments. This must be confirmed by specific tests on a tissue sample.
  • The patient must have cancer that can be measured or assessed by the doctor using specific guidelines.
  • The patient must be at least 18 years old or the legal age of adulthood in their country.
  • The patient must have a good general health status, as determined by a specific scale used by doctors (ECOG performance status of 0 or 1).
  • The patient must have adequate blood cell counts, which means having enough white blood cells, platelets, and hemoglobin.
  • The patient must have adequate liver function, which means certain liver enzymes and bilirubin levels must be within acceptable limits.
  • The patient must have adequate kidney function, as determined by a specific test that measures how well the kidneys are working.
  • The patient must have a normal heart function, as determined by specific heart tests.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Women and men with partners who can have children must agree to use two methods of birth control during the study and for a certain period after the study ends.
  • Women must agree not to donate eggs during the study and for a certain period after the study ends.
  • Men must agree to use condoms and not to donate sperm during the study and for a certain period after the study ends.
  • The patient must have a life expectancy of more than 3 months, according to the doctor.
  • The patient must agree to participate in the study by signing a written consent form. If the patient is being tested for HER2 status before the study, they must provide separate consent for the use of their tumor tissue.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than biliary tract cancer cannot participate. Biliary tract cancer affects the tubes that carry bile, a fluid made by the liver, to the small intestine.
  • Patients who are not positive for HER2 (human epidermal growth factor receptor 2) cannot participate. HER2 is a protein that can affect the growth of cancer cells.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not able to give informed consent or understand the study cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments or medications recently that might interfere with the study cannot participate.
  • Patients who have allergies to the study drugs or similar drugs cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
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Investigated drugs

  • Zanidatamab

    is a medication being tested for its ability to treat advanced HER2 positive biliary tract cancer. It is used in combination with other standard treatments to see if it can improve outcomes for patients with this type of cancer.

  • Cisplatin

    is a chemotherapy drug that is commonly used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing.

  • Gemcitabine

    is another chemotherapy medication used to treat different cancers, including biliary tract cancer. It works by interfering with the DNA replication process in cancer cells, which helps to stop their growth.

  • PD-1/PD-L1 Inhibitors

    are a type of immunotherapy that helps the immune system recognize and attack cancer cells. These inhibitors block the proteins that prevent the immune system from attacking the cancer, allowing it to work more effectively against the tumor.

What is already known about the treatment

Zanidatamab – Zanidatamab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced HER2-positive biliary tract cancer. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for zanidatamab is biliary tract cancer, specifically targeting tumors that overexpress the HER2 protein. At the molecular level, zanidatamab works by binding to the HER2 receptor on cancer cells, blocking the signals that promote tumor growth and survival. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Biliary Tract Cancer – Biliary tract cancer is a type of cancer that occurs in the bile ducts, gallbladder, or ampulla of Vater. It often begins in the cells lining the bile ducts and can spread to nearby tissues and organs. The disease may cause symptoms such as jaundice, abdominal pain, and weight loss as it progresses. Biliary tract cancer can be classified into different types based on its location, including intrahepatic, perihilar, and distal bile duct cancers. The progression of the disease can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection is challenging due to the deep location of the biliary tract and the nonspecific nature of early symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508219-21-00Protocol codeJZP598-302Estimated enrolment247 patientsSponsorJazz Pharmaceuticals Ireland Limited

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