Upon joining the trial, a written informed consent form must be signed. This is to confirm understanding and agreement to participate in the study.

During the screening phase, eligibility is assessed. This includes confirming a diagnosis of advanced biliary cancer and ensuring the presence of a suitable tumor sample for analysis.

Basic health assessments are conducted, including blood tests and imaging, to ensure adequate organ function and overall health status.

The initial treatment involves receiving four cycles of the first-line standard of care (1L-SoC) therapy. This is a common treatment for advanced biliary cancer.

The response to this treatment is monitored to determine if the disease is stable or responsive.

If the disease is stable or responsive after the initial treatment, randomization occurs. This means being assigned to either continue with the standard treatment or switch to a targeted maintenance therapy based on the tumor’s molecular profile.

If assigned to the targeted maintenance therapy, specific medications are administered. These may include oral medications like futibatinib, neratinib, or binimetinib, or intravenous medications like cisplatin or gemcitabine.

The dosage and frequency depend on the specific medication and the treatment plan outlined by the healthcare team.

Regular visits are scheduled to monitor health status and response to treatment. This includes physical exams, blood tests, and imaging studies.

Adjustments to the treatment plan may be made based on these assessments.

Participation in the trial continues until the end of the study period or until it is determined that the treatment is no longer effective.

At the end of participation, a final assessment is conducted to evaluate overall health and treatment outcomes.