Hepatobiliary cancer Trials in Disease

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial is testing a new medication called DS-3939a for patients with advanced or metastatic solid tumors, including cancers of the bile duct (biliary tract cancer). The medication is given directly into the bloodstream through an intravenous infusion.

Who can participate: Patients must be at least 18 years old with confirmed advanced cancer that has spread or cannot be surgically removed. Specific cancer types include bladder, lung, breast, ovary, bile duct, and pancreatic cancers. Participants need to have good organ function, with a heart pumping efficiency of at least 50%. The cancer must be measurable using standard medical criteria, and patients should be active enough to carry out light work or be fully active (ECOG score of 0 or 1). For the second part of the study, patients must show disease progression on scans during or after their most recent treatment and provide a tumor sample.

Who cannot participate: The trial excludes patients who do not meet the age requirements or who belong to vulnerable groups such as pregnant women or those unable to give informed consent. Patients who do not meet the safety requirements for DS-3939a also cannot join.

Study goals: The trial has two parts. The first part focuses on evaluating the safety and tolerability of DS-3939a to understand how the body handles the medication and whether it causes harmful side effects. The second part continues safety monitoring while measuring how effectively the treatment works at a recommended dose by tracking the objective response rate, which means measuring how much the cancer shrinks or responds to treatment.

Investigational drug: DS-3939a is an experimental medication designed to treat advanced solid tumors. It targets specific pathways that cancer cells use to grow and spread, though the exact mechanism is still being studied. This medication is currently in clinical trials and not yet approved for general use.

Study of Fadraciclib in Adults with Advanced Solid Tumors (Including Breast, Colorectal, Endometrial, Ovarian, Biliary Tract, and Liver Cancer) and Lymphoma

This clinical trial investigates fadraciclib, also known as CYC065, for adults with various advanced cancers including biliary tract cancer and hepatocellular carcinoma (liver cancer). The medication is taken by mouth in tablet form.

Who can participate: Patients must be 18 years or older with confirmed advanced cancer that has either progressed despite standard treatment, cannot tolerate standard treatment, or for which no standard treatment exists. Participants need an ECOG performance status of 0 or 1, meaning they can carry out normal activities with minimal restrictions. Laboratory tests must meet specific requirements, and patients must be able to swallow and keep down oral medication without significant digestive problems. Women who can become pregnant and men who can father children must use effective birth control during the study and for 6 months afterward. A negative pregnancy test within 7 days before starting treatment is required for women of childbearing potential.

Who cannot participate: The trial excludes patients who have received CDK inhibitor drugs within 14 days before the study start, those with active brain metastases or spinal cord compression requiring treatment, or those who had major surgery within 4 weeks. Patients with serious heart conditions (uncontrolled high blood pressure, unstable heart disease, recent heart attack, or abnormal heart rhythm requiring medication) cannot participate. Other exclusions include active uncontrolled infections, known HIV or active hepatitis B or C, other active cancers requiring treatment, pregnancy or breastfeeding, inability to swallow oral medications, and known allergies to the study medication.

Study goals: The study aims to find the best dose of fadraciclib and determine how well it works in treating different types of advanced cancer. Participants take the medication either once or twice daily in 28-day cycles, continuing as long as it helps and side effects are manageable. Doctors monitor participants' health and cancer response through regular check-ups and medical tests. The study tracks how the cancer responds using standard medical criteria, how long the treatment remains effective, and overall health and survival. The study is scheduled to continue until October 30, 2025.

Investigational drug: Fadraciclib (CYC065) is an oral medication that works by blocking specific proteins called CDK2 and CDK9, which are involved in cell division and growth. By inhibiting these proteins, the medication may stop or slow the progression of cancer cells. It is designed for patients whose cancer has returned after previous treatments or has not responded to standard therapies.

Summary

Currently, 2 clinical trials are actively recruiting patients with hepatobiliary cancer and related advanced solid tumors in Europe. Both studies focus on experimental medications with different mechanisms of action: DS-3939a is administered intravenously and targets specific cancer cell pathways, while fadraciclib is an oral CDK2/9 inhibitor taken in tablet form.

Spain is the only country where both trials are available, providing patients there with two potential treatment options. The DS-3939a trial is also recruiting in Belgium and France, expanding access across multiple European countries. Both studies accept patients with biliary tract cancer, and the fadraciclib trial also includes hepatocellular carcinoma patients.

These trials are designed for patients with advanced cancer who have limited treatment options, either because standard treatments have stopped working, are not tolerated, or do not exist. Participants should carefully review the eligibility criteria with their healthcare providers to determine which trial might be suitable for their specific situation.