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Study on BI 907828 for Patients with Advanced Biliary Tract, Pancreatic, Lung, or Bladder Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called BI 907828 on certain types of cancer. The cancers being studied include biliary tract cancer, which affects the bile ducts, gallbladder, and ampulla of Vater; pancreatic cancer, specifically pancreatic ductal adenocarcinoma; lung cancer, specifically lung adenocarcinoma; and bladder cancer, specifically urothelial bladder cancer. These cancers are known to be locally advanced or have spread to other parts of the body, making them challenging to treat with standard therapies.

The purpose of this study is to evaluate how effective and safe BI 907828 is when used alone in treating these cancers. The study will involve patients who have specific genetic characteristics, such as MDM2 amplification and TP53 wild-type status, which are important for the treatment to potentially work. Participants will take the medication in the form of a film-coated tablet by mouth. The study will monitor the patients over a period of time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, patients will be closely observed to assess the treatment's impact on their cancer and overall health. The study aims to gather information on how long the treatment can control the disease, how long patients live after starting the treatment, and any changes in their quality of life. This information will help determine if BI 907828 could be a beneficial treatment option for these types of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will provide a signed and dated informed consent form. This is a requirement before any trial-specific procedures can begin.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of a solid tumor that fits the trial's criteria, such as biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, lung adenocarcinoma, or urothelial bladder cancer.

    A pathology report or molecular profiling report will be reviewed to confirm MDM2 amplification and TP53 wild-type status. Tissue samples may be required for retrospective confirmation.

  3. Step 3

    Treatment administration

    The patient will begin treatment with BI 907828, which is administered as a film-coated tablet taken orally.

    The dosage and frequency of administration will be determined by the trial protocol and the patient's specific condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's response to the treatment will be monitored. This includes assessing the objective response, progression-free survival, and overall survival.

    Regular follow-up visits will be scheduled to evaluate the patient's health and any side effects experienced during the treatment.

  5. Step 5

    End of treatment

    At the end of the treatment period, the patient's overall response to the therapy will be reviewed. This includes measuring the duration of the objective response and any changes in quality of life scores.

    The occurrence of any treatment-emergent adverse events will also be documented.

Who can join the trial?

15 criteria

  • Have a diagnosis of a solid tumor that fits into one of the study groups:
    • Biliary tract adenocarcinoma: Cancer in the bile ducts, gallbladder, or near the pancreas. The disease must be advanced and cannot be removed by surgery. Patients should have tried all standard treatments that could help, or the doctor believes they won't benefit from them.
    • Pancreatic ductal adenocarcinoma: Advanced cancer in the pancreas that cannot be removed by surgery. Patients should have tried all standard treatments that could help.
    • Lung adenocarcinoma: Advanced cancer in the lungs that cannot be removed by surgery. Patients should have tried all standard treatments that could help.
    • Urothelial bladder cancer: Advanced cancer in the bladder that cannot be removed by surgery. Patients should have tried all standard treatments that could help.
    • Sign a written consent form agreeing to participate in the study.
    • Be at least 18 years old.
    • If able to have children, agree to use two reliable birth control methods during the study and for a specified time after the last dose of the study drug.
    • Have a pathology report showing specific genetic markers: MDM2 amplification (a type of genetic change) and TP53 wild-type status (a normal version of a specific gene). This must be confirmed with a tissue test, not a blood test.
    • Provide a sample of previous tumor tissue for further testing.
    • Have at least one measurable tumor according to specific medical guidelines.
    • Have a good general health status, as measured by a specific scale (ECOG performance status of 0 or 1).
    • Agree to give blood samples for study-related tests.
    • Have organs that are working well enough, as specified in the study details.
    • Any side effects from previous cancer treatments should be mild or gone, except for hair loss, menstrual issues, or mild nerve problems.
    • Have a life expectancy of at least 3 months, according to the doctor.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer than those specified in the study cannot participate. The study is only for certain types of cancer, such as biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, urothelial bladder cancer, and lung adenocarcinoma.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

BI 907828 is an investigational medication being studied for its potential to treat certain types of cancer. It is being tested in patients with specific genetic characteristics, such as MDM2 amplification and TP53 wild-type status. The trial aims to evaluate how effective and safe this medication is when used alone in treating various advanced or metastatic cancers, including biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, lung adenocarcinoma, and urothelial bladder cancer.

What is already known about the treatment

BI 907828 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, including biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, urothelial bladder cancer, and lung adenocarcinoma. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication for BI 907828 is the treatment of cancers that are locally advanced or metastatic, particularly those with MDM2 amplification and TP53 wild-type status. At the molecular level, BI 907828 works by inhibiting the MDM2 protein, which can lead to the activation of the p53 tumor suppressor pathway, potentially stopping cancer cell growth. It is classified as an MDM2 inhibitor in pharmacology.

Investigated diseases

  • Biliary tract adenocarcinoma

    This is a type of cancer that originates in the bile ducts, which are responsible for carrying bile from the liver to the small intestine. It can also occur in the gallbladder and the ampulla of Vater. The disease often progresses slowly, with symptoms appearing as the tumor grows and obstructs the bile ducts. Common symptoms include jaundice, abdominal pain, and weight loss. As the cancer advances, it may spread to nearby organs and tissues.

  • Pancreatic ductal adenocarcinoma

    This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It typically grows and spreads rapidly, often leading to symptoms such as abdominal pain, weight loss, and jaundice. The disease is often diagnosed at an advanced stage due to its subtle early symptoms. As it progresses, it can invade nearby organs and spread to distant parts of the body.

  • Urothelial bladder cancer

    This cancer begins in the urothelial cells lining the bladder. It can vary in aggressiveness, with some tumors growing slowly and others spreading quickly. Symptoms often include blood in the urine, frequent urination, and pain during urination. As the disease progresses, it may invade deeper layers of the bladder wall and spread to other parts of the body.

  • Lung adenocarcinoma

    This is a common type of non-small cell lung cancer that originates in the glandular cells of the lung. It often grows in the outer regions of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. The disease can progress to involve lymph nodes and distant organs, making early detection challenging.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506369-79-00Protocol code1403-0011Estimated enrolment157 patientsSponsorBoehringer Ingelheim Espana S.A.

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