Ongoing Clinical Trials for Biliary Neoplasm
This article provides information about 6 ongoing clinical trials for biliary neoplasm (also known as biliary tract cancer, bile duct cancer). These trials are testing various investigational treatments including targeted therapies, immunotherapies, and chemotherapy combinations across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer
- Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors
- Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer
- Study on BI 907828 for Patients with Advanced Biliary Tract, Pancreatic, Lung, or Bladder Cancer
- France
- Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer
- Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors
- Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer
- Study on BI 907828 for Patients with Advanced Biliary Tract, Pancreatic, Lung, or Bladder Cancer
- Germany
- Hungary
- Ireland
- Italy
- Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer
- Study on Cisplatin, Gemcitabine, and Paclitaxel Albumin-Bound for Patients with Resectable Biliary Tract Cancer at High Risk of Recurrence
- Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors
- Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers
- Netherlands
- Poland
- Portugal
- Spain
- Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer
- Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors
- Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers
- Study on BI 907828 for Patients with Advanced Biliary Tract, Pancreatic, Lung, or Bladder Cancer
Study of AZD8205 Alone or with Other Cancer Drugs for Patients with Advanced Breast, Biliary Tract, Ovarian, and Endometrial Cancer
This trial is testing a new investigational medication called AZD8205, which is being studied for patients with advanced or metastatic cancers, including biliary tract cancer. The medication is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein.
Inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of advanced cancer that has returned or spread after receiving standard treatment. For biliary tract cancer patients specifically, the disease must be getting worse despite previous therapies. Patients must have at least one measurable tumor, an ECOG performance status of 0-1, meaning they are able to carry out light work despite some symptoms, and a life expectancy of at least 12 weeks. Good organ and bone marrow function is required, and patients must be willing to use contraception during the study.
Exclusion criteria: Patients with a different type of cancer than those specified in the study cannot participate. Those who do not meet the specific health requirements set by the study or who are part of a vulnerable population requiring special protection are also excluded.
Trial focus: The main goal is to evaluate the safety and tolerability of AZD8205 and to determine the best dose for future studies. The trial will monitor patients closely to observe any side effects and to understand how the body processes the drug. Researchers will measure changes in tumor size and monitor the overall health of participants. The study is expected to continue until mid-2025.
Study on Cisplatin, Gemcitabine, and Paclitaxel Albumin-Bound for Patients with Resectable Biliary Tract Cancer at High Risk of Recurrence
This Italian trial is comparing two different treatment approaches for patients with biliary tract cancer that can be surgically removed but is at high risk of coming back. The study involves Cisplatin, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Bound (also called Nab-paclitaxel).
Inclusion criteria: Patients must be between 18 and 74 years old with a confirmed diagnosis of resectable biliary tract cancer that has not been previously surgically removed. They must be at high risk for cancer returning based on specific features. Patients need an ECOG performance status of 0-1, adequate blood, liver, and kidney function, and a life expectancy of more than 3 months. Women of childbearing potential must have a negative pregnancy test, and all participants must agree to use effective birth control during the study and for 7 months afterward.
Exclusion criteria: Patients with any other type of cancer besides resectable biliary tract cancer cannot participate. Those who are pregnant or breastfeeding, have participated in another clinical trial recently, have serious infections or allergic reactions to study medications, or who are unable to give informed consent are also excluded.
Trial focus: The study is comparing whether receiving chemotherapy before surgery is more effective in preventing cancer recurrence within 12 months compared to having surgery immediately. Participants are randomly assigned to either receive chemotherapy first or proceed directly to surgery. The trial monitors patients’ health and quality of life over time to determine which approach reduces the risk of cancer returning.
Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors
This multi-country trial is studying Ifinatamab deruxtecan (also known as DS-7300a or I DXd), an antibody-drug conjugate being tested on various types of cancers that have either come back or spread, including biliary tract cancer. The medication is given through intravenous infusion.
Inclusion criteria: Participants must be at least 18 years old with recurrent or metastatic cancer. They must have at least one measurable tumor on CT or MRI scan and an ECOG performance status of 0 or 1. Adequate organ function is required, including specific requirements for blood counts, liver function, and kidney function. Patients must have documented disease progression after previous treatments. For biliary tract cancer patients specifically, they must have received prior platinum-based therapy or immune checkpoint inhibitors unless ineligible for these treatments.
Exclusion criteria: Patients who do not have target lesions that can be measured according to RECIST v1.1 criteria are not eligible. Those who are not within the specified age range or who are part of a vulnerable population are also excluded.
Trial focus: The study aims to evaluate how effective and safe Ifinatamab deruxtecan is in shrinking tumors. The medication works by targeting specific proteins on cancer cells and delivering a toxic substance directly into them, which may help kill the cells or stop them from growing. Regular monitoring visits track the body’s response to treatment and ensure patient safety.
Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer
This French and Belgian trial is testing a personalized treatment approach using molecular targeted therapy (MTT) for advanced biliary cancer. The medications being studied include Cisplatin, Durvalumab (IMFINZI), Trastuzumab (Zercepac), Futibatinib, Niraparib, Neratinib (Nerlynx), Binimetinib (Mektovi), Zanidatamab, Encorafenib (Braftovi), and Ivosidenib.
Inclusion criteria: Patients must be at least 18 years old with a confirmed diagnosis of advanced biliary cancer. They must have a molecular profile showing at least one targetable genetic change that can be treated with a study drug. After receiving 4 cycles of first-line standard treatment, patients must have disease control (stable or responsive). They need an ECOG performance status of 0 or 1, adequate organ function, a life expectancy of more than 3 months, and adequate biliary drainage with no ongoing infection. Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the trial.
Exclusion criteria: Patients who have not completed 4 cycles of first-line treatment or who have not responded to it cannot participate. Those who are pregnant or breastfeeding, have severe medical conditions, known allergies to study medications, participated in another trial recently, or have a history of drug or alcohol abuse are also excluded.
Trial focus: After initial standard treatment, patients are randomly assigned to either continue standard treatment or switch to personalized targeted therapy based on their tumor’s specific genetic characteristics. The goal is to determine if the personalized approach is more effective in preventing cancer progression compared to standard treatment.
Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers
This Spanish and Italian trial is evaluating MK-2870, a humanized IgG1 monoclonal antibody, for patients with gastrointestinal cancers including biliary tract cancer. The medication is administered through intravenous infusion.
Inclusion criteria: Patients must have unresectable (cannot be removed by surgery) or metastatic cancer. For biliary tract cancer specifically, patients must have advanced and/or unresectable disease and have received one or two previous treatments. Patients must have recovered from any side effects caused by previous cancer treatment.
Exclusion criteria: The trial does not specify detailed exclusion criteria beyond requiring patients to have one of the specified cancer types and to have received appropriate prior treatments.
Trial focus: The study aims to assess the safety and effectiveness of MK-2870 in shrinking tumors or stopping their growth. It is being tested both as a standalone treatment and in combination with other anticancer agents. Researchers will monitor patients for side effects and how their cancer responds to the treatment, tracking metrics such as duration of response, progression-free survival, and overall survival.
Study on BI 907828 for Patients with Advanced Biliary Tract, Pancreatic, Lung, or Bladder Cancer
This trial across Austria, France, Belgium, Germany, and Spain is studying BI 907828, an MDM2 inhibitor, for patients with advanced biliary tract cancer and other cancers. The medication is taken as a film-coated tablet by mouth.
Inclusion criteria: Patients must be at least 18 years old with a confirmed diagnosis of biliary tract adenocarcinoma (including bile duct, gallbladder, or ampullary cancer) that is advanced and cannot be removed by surgery. They must have tried all standard treatments or the doctor believes they won’t benefit from them. Critically, patients must have specific genetic characteristics confirmed by tissue testing: MDM2 amplification and TP53 wild-type status. They must have at least one measurable tumor, an ECOG performance status of 0 or 1, adequate organ function, and a life expectancy of at least 3 months. Women of childbearing potential must agree to use two reliable birth control methods.
Exclusion criteria: Patients with different types of cancer than those specified, those not within the age range, or those part of a vulnerable population cannot participate.
Trial focus: The study evaluates how effective and safe BI 907828 is when used alone in treating cancers with specific genetic characteristics. The medication works by inhibiting the MDM2 protein, which can activate the p53 tumor suppressor pathway and potentially stop cancer cell growth. The trial monitors patients over time to see how their cancer responds and to check for any side effects, including assessing progression-free survival, overall survival, and quality of life changes.
Summary
The 6 ongoing clinical trials for biliary neoplasm reflect a diverse approach to treating this challenging disease. The trials are concentrated primarily in Western European countries, with France, Belgium, Italy, and Spain hosting multiple studies. This geographical distribution suggests strong research infrastructure and clinical expertise in these regions.
The investigational treatments span several therapeutic approaches. Some trials focus on novel targeted therapies like AZD8205 and BI 907828, which target specific molecular pathways in cancer cells. Others are testing antibody-drug conjugates such as Ifinatamab deruxtecan, which deliver toxic substances directly to cancer cells. There are also studies combining traditional chemotherapy agents like cisplatin and gemcitabine with newer approaches, as well as personalized medicine strategies that tailor treatment based on individual tumor genetics.
A notable feature across these trials is the emphasis on patient selection based on genetic markers. Several studies require specific molecular characteristics such as MDM2 amplification or particular tumor profiles, reflecting the shift toward precision medicine in cancer treatment. Most trials are designed for patients with advanced or metastatic disease who have already received standard treatments, indicating these are testing options for patients with limited alternative therapies.
The variety of administration methods ranges from intravenous infusions to oral tablets, offering potential flexibility in treatment delivery. Trial durations vary, with some expected to continue through 2025 and beyond, demonstrating the long-term commitment required to properly evaluate these investigational treatments.
