Ongoing Clinical Trials for Malignant Neoplasm of Ampulla of Vater
There is currently 1 ongoing clinical trial for malignant neoplasm of ampulla of Vater. This trial is investigating a targeted therapy called BAY 2927088 for patients with advanced solid tumors that have a specific genetic change known as a HER2 mutation. The study is being conducted across multiple European countries including Denmark, Italy, France, and Spain.
Clinical trial locations
- Denmark
- France
- Italy
- Spain
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This trial is investigating a new treatment option for people with advanced solid tumors that carry a specific genetic change called a HER2 mutation. The investigational medication, BAY 2927088, is taken orally as a coated tablet and works by blocking certain proteins called tyrosine kinases that help cancer cells grow and spread.
Who can participate:
- Adults aged 18 years or older
- People with advanced solid tumors that cannot be removed by surgery, including cancers such as colorectal cancer, biliary tract cancer (which includes cancer of the ampulla of Vater), bladder and urinary tract cancer, cervical cancer, endometrial cancer, and other solid tumors (excluding lung cancer)
- Those who have already tried standard treatments for their specific type and stage of cancer, or have no other satisfactory treatment options available
- Patients whose cancer has been confirmed to have an activating HER2 mutation through genetic testing
- Those with at least one tumor area that can be measured and tracked according to standard guidelines
Who cannot participate:
- Patients without a confirmed HER2 mutation in their cancer
- People who are pregnant or breastfeeding
- Those with certain medical conditions that could interfere with the study
- Patients with allergies or reactions to the study medication
- Those who have recently participated in another clinical trial
- People unwilling or unable to follow the study procedures
What the trial involves:
The main goal of this study is to learn how well BAY 2927088 works in shrinking tumors or stopping them from growing, and to understand how safe the treatment is. Participants will take the medication by mouth for up to 36 months. Throughout the trial, regular monitoring will include imaging tests to measure tumor size and blood tests to check for any side effects.
The study follows a structured approach. After confirming eligibility through initial assessments, participants begin treatment with BAY 2927088 tablets. The dosage and frequency are determined by the study protocol and the healthcare team. Regular monitoring includes imaging to assess how the tumors respond to treatment, safety checks for any adverse effects, and quality of life evaluations using standardized questionnaires focusing on physical functioning and overall health.
This research is particularly important because it targets a specific genetic change in cancer cells, offering a more personalized approach to treatment. The reversible tyrosine kinase inhibitor works specifically on the HER2 mutation pathway, which is involved in uncontrolled cell growth in certain cancers. The trial is expected to continue until October 2027, providing long-term information about the effectiveness and safety of this targeted therapy.
Summary
Currently, there is one clinical trial available for patients with malignant neoplasm of ampulla of Vater, focusing on those whose tumors have HER2 mutations. This trial is being conducted across four European countries: Denmark, France, Italy, and Spain, providing access to patients in multiple locations.
The study represents an important development in targeted cancer therapy, focusing on a specific genetic change rather than treating all cancers of this type the same way. The oral medication being tested, BAY 2927088, offers a non-invasive treatment option that patients can take at home, which may improve quality of life compared to some traditional cancer treatments.
Patients interested in participating should discuss with their healthcare provider whether genetic testing has confirmed a HER2 mutation in their tumor, and whether they meet the other eligibility criteria. The trial’s focus on patients who have already tried standard treatments or have no other satisfactory options highlights its potential role for those with limited treatment alternatives.
