Ongoing Clinical Trials for Biliary Cancer Metastatic
This article provides information about 3 ongoing clinical trials investigating new treatments for biliary cancer that has spread to other parts of the body (metastatic biliary cancer). These trials are testing different investigational medications and drug combinations to help patients whose cancer has advanced beyond the bile ducts to other areas.
Clinical trial locations
- Belgium
- France
- Poland
- Spain
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is testing a new medication called DS-3939a, which is given directly into the bloodstream through a vein. The study is designed to evaluate whether this medication is safe and how well the body tolerates it when treating various types of advanced cancers, including those of the bile duct.
Who can participate: Patients eligible for this trial must have confirmed advanced or metastatic cancer, including bile duct cancer that cannot be removed by surgery. Key requirements include having adequate organ function and a heart that is pumping blood effectively (at least 50% ejection fraction). Participants should be able to carry out daily activities with minimal symptoms, reflected in an Eastern Cooperative Oncology Group performance status score of 0 or 1. The trial includes two parts: Part 1 accepts patients with locally advanced or metastatic bile duct cancer regardless of specific cancer types, while Part 2 requires evidence that the cancer has progressed during or after the most recent treatment.
Who cannot participate: Patients who are part of vulnerable populations, such as pregnant women or those unable to provide consent, cannot join. Those outside the specified age range or who do not meet the safety requirements for DS-3939a are also excluded.
What the study aims to achieve: The trial is divided into two parts. The first part focuses on understanding the safety of DS-3939a and any side effects it may cause. The second part continues to evaluate safety while also measuring how effective the treatment is at shrinking or controlling tumors. Throughout the study, participants will undergo regular check-ups, laboratory tests, and imaging studies to monitor their health and track how the cancer responds to treatment.
Investigational drug: DS-3939a is an experimental medication designed to target specific pathways that cancer cells use to grow and spread. The exact mechanism is still being investigated, but it represents a new approach to treating advanced solid tumors.
Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2
This clinical trial is investigating a new treatment called AZD0901, both alone and in combination with other cancer medications. The study focuses on cancers that express a specific protein called Claudin 18.2 on their cells, which can include certain bile duct cancers.
Who can participate: Participants must be at least 18 years old and have confirmed advanced or metastatic cancer with tumors that test positive for the Claudin 18.2 protein. Patients need to have at least one tumor that can be measured and must have adequate organ function, including proper functioning of the liver, kidneys, and bone marrow. They should have good general health with an ECOG performance status of 0 to 1, and weigh more than 35 kg. A tumor sample, either from a previous biopsy or a new one, must be provided for testing.
Who cannot participate: Patients whose tumors do not express the Claudin 18.2 protein cannot join the study. Those who are not within the specified age range, cannot safely tolerate the study treatment, or belong to vulnerable populations not designed to be included in the trial are also excluded.
What the study aims to achieve: The trial will evaluate the safety and tolerability of AZD0901 and assess its effectiveness in reducing tumor size or slowing cancer growth. Participants will receive treatments through intravenous infusions, which may include combinations with other cancer medications such as irinotecan, folinic acid, gemcitabine, and fluorouracil. Regular monitoring will track side effects, changes in laboratory results, and tumor response through imaging studies.
Investigational drug: AZD0901 is a medication that targets the Claudin 18.2 protein on cancer cells. By targeting this specific protein, the treatment aims to disrupt the growth and survival of cancer cells while potentially working together with other cancer therapies.
Study Comparing Ivonescimab to FOLFOX Drug Combination for Patients with Advanced Biliary Tract Cancer
This trial is specifically designed for patients with advanced biliary tract cancer and is comparing a new treatment called ivonescimab with a standard chemotherapy regimen known as FOLFOX. This study is being conducted as a second-line treatment, meaning it is offered to patients whose first treatment was not successful.
Who can participate: Eligible participants must have confirmed bile duct cancer or gallbladder cancer that is locally advanced and cannot be removed by surgery, or that has spread to other parts of the body. Patients must have experienced disease progression after receiving standard first-line treatment and be suitable for second-line treatment with FOLFOX chemotherapy. They need to have proper biliary drainage with no ongoing infection, adequate organ function including bone marrow, liver, kidneys, and heart, and at least one tumor that can be measured. An ECOG performance status of 0 or 1 is required, indicating the ability to carry out daily activities. Patients must also have had recent endoscopy procedures and treatment of any enlarged veins if needed.
Who cannot participate: Pregnant or breastfeeding women cannot participate. Patients who have recently participated in another clinical trial, have medical conditions that could interfere with study results or pose health risks, or are unable to provide informed consent are excluded. Those outside the specified age range or unable to follow study procedures also cannot join.
What the study aims to achieve: The trial aims to determine whether ivonescimab is more effective than FOLFOX in treating advanced biliary tract cancer. Participants will be randomly assigned to receive either ivonescimab or the FOLFOX combination of drugs through intravenous injections. The study will monitor how long patients live without their cancer worsening, overall survival rates, disease control rates, and quality of life throughout the treatment period.
Investigational drugs: Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF. This dual-action approach is designed to help the immune system fight cancer cells while blocking the growth of new blood vessels that tumors need to survive. FOLFOX is a combination of standard chemotherapy drugs (oxaliplatin, fluorouracil, and calcium folinate) used as the comparison treatment in this trial.
Summary
These three clinical trials represent different approaches to treating metastatic biliary cancer. The trials are being conducted across multiple European countries, with France hosting two of the three studies, and Spain participating in two trials as well. Belgium and Poland each host one trial.
The trials showcase a range of investigational approaches, from DS-3939a targeting cancer growth pathways, to AZD0901 focusing on tumors expressing the Claudin 18.2 protein, to ivonescimab using a dual-action immunotherapy strategy. Notably, one trial specifically targets biliary tract cancer as a second-line treatment, while the other two include bile duct cancer within broader studies of advanced solid tumors.
Patients interested in participating should note that each trial has specific requirements regarding previous treatments, tumor characteristics, and overall health status. All trials involve intravenous administration of medications and require regular monitoring throughout the treatment period.
