Ongoing Clinical Trials for HER2 Positive Biliary Tract Cancer
There are currently 2 ongoing clinical trials investigating new treatment options for patients with HER2 positive biliary tract cancer. These studies are testing different combinations of targeted therapies and chemotherapy drugs to improve outcomes for people with this advanced form of cancer. The trials are being conducted across multiple European countries, offering patients access to innovative treatment approaches.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Finland
- France
- Germany
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Study of Trastuzumab Deruxtecan and Rilvegostomig for Patients with Advanced HER2-positive Biliary Tract Cancer
This clinical trial is comparing a new treatment combination against the current standard therapy for advanced HER2-positive biliary tract cancer. The study aims to find out if the new approach can improve how long patients live compared to existing treatments.
Who can participate:
This study is open to adults aged 18 years or older who have HER2-positive biliary tract cancer that cannot be removed by surgery or has spread to other parts of the body. Participants must not have received previous treatment for their advanced disease, although treatment given around the time of surgery is allowed if it was completed more than 6 months before the cancer became advanced. The cancer must be confirmed as HER2-expressing with a score of IHC 3+ or IHC 2+, and a tumor sample no older than 3 years must be available for analysis. Participants need to have at least one area of cancer that can be measured, be fully active or have only minor symptoms, and have adequate organ and bone marrow function. Women who can become pregnant must have a negative pregnancy test.
Who cannot participate:
The trial excludes patients who have any cancer other than HER2-positive biliary tract cancer, those with serious heart conditions or uncontrolled infections, pregnant or breastfeeding women, and people who have recently participated in another clinical trial. Patients with known allergies to the study medications, severe liver or kidney problems, or those unable to follow study procedures are also excluded.
What the study involves:
Participants will be randomly assigned to receive either the new treatment combination or the standard treatment. The new treatment includes two medications called trastuzumab deruxtecan and rilvegostomig, both given through an intravenous infusion. Trastuzumab deruxtecan is an antibody-drug conjugate that targets the HER2 protein on cancer cells and delivers a powerful anti-cancer drug directly to them. Rilvegostomig is a bispecific monoclonal antibody that enhances the immune system’s ability to fight cancer.
The standard treatment includes three medications: gemcitabine and cisplatin (both chemotherapy drugs that interfere with cancer cell DNA), and durvalumab (an immunotherapy drug that helps the immune system recognize and attack cancer cells). Throughout the study, participants will undergo regular monitoring including physical exams, blood tests, and imaging studies. After completing treatment, follow-up visits will continue to monitor long-term health outcomes.
Study on Zanidatamab with Cisplatin and Gemcitabine for Advanced HER2 Positive Biliary Tract Cancer Patients
This clinical trial is testing whether adding a medication called zanidatamab to standard chemotherapy can improve outcomes for patients with advanced HER2-positive biliary tract cancer. The study will compare the new treatment combination with standard treatment alone.
Who can participate:
This study is for adults (at least 18 years old or the legal age of adulthood in their country) who have confirmed HER2-positive biliary tract cancer that is locally advanced or has spread to other parts of the body and cannot be treated with surgery or other curative approaches. Participants must not have received more than 2 cycles of specific chemotherapy treatments (gemcitabine and cisplatin, with or without certain immune therapy drugs). The HER2-positive status must be confirmed by specific laboratory tests on a tissue sample. Participants need to have cancer that can be measured by doctors, be in good general health (able to carry out normal daily activities with few symptoms), and have adequate blood cell counts, liver function, kidney function, and heart function. Women who can become pregnant must have a negative pregnancy test, and both women and men must agree to use two methods of birth control during the study and for a period afterward. Participants must have a life expectancy of more than 3 months.
Who cannot participate:
Patients with a different type of cancer other than biliary tract cancer, those who are not HER2-positive, pregnant or breastfeeding women, and people who cannot give informed consent or understand the study are excluded. Those with other serious health conditions that might interfere with the study, recent participation in another clinical trial, allergies to the study drugs, or who have received certain treatments or medications recently that might interfere with the study cannot participate.
What the study involves:
Participants will be randomly assigned to one of the treatment groups. The treatment includes a combination of medications given through intravenous administration. The main drug being tested is zanidatamab, which is a monoclonal antibody that binds to the HER2 receptor on cancer cells, blocking signals that promote tumor growth. This will be given alongside standard chemotherapy drugs gemcitabine and cisplatin, which work by damaging cancer cell DNA to prevent their growth. Some participants may also receive a PD-1/PD-L1 inhibitor such as durvalumab or pembrolizumab, which are immunotherapy drugs that help the immune system recognize and attack cancer cells.
Treatment is given in cycles lasting a few weeks, with the specific dosage and frequency determined by the study protocol and each participant’s health status. Throughout the study, regular monitoring will include medical examinations, blood tests, and imaging studies to evaluate how the cancer is responding to treatment. Participants will need to report any side effects or changes in their health. After completing treatment cycles, participants will enter a follow-up phase where their health continues to be monitored to assess long-term outcomes.
Summary
Both ongoing clinical trials for HER2-positive biliary tract cancer are investigating innovative approaches that combine targeted therapies with existing treatments. These studies are widely available across Europe, with trials being conducted in multiple countries including Austria, Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, and Sweden. This broad geographical distribution provides patients in many European countries with access to these investigational treatments.
A common thread in both trials is the focus on targeting the HER2 protein, which is overexpressed in this type of cancer and can promote tumor growth. The first trial tests trastuzumab deruxtecan and rilvegostomig as a new treatment approach, while the second evaluates zanidatamab combined with standard chemotherapy. Both studies aim to determine whether these new combinations can improve patient survival and outcomes compared to current standard treatments.
All participants in these trials will receive careful monitoring throughout treatment and follow-up periods, allowing researchers to gather comprehensive information about both the effectiveness and safety of these investigational approaches. These trials represent important steps in the search for better treatment options for patients with advanced HER2-positive biliary tract cancer.
