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Study on Long-Term Safety of BI 907828 for Patients with Solid Tumors Who Previously Participated in a Study with This Medicine

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 long-term safety of a medication called brigimadlin in patients with solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study involves patients who have already participated in a previous trial with brigimadlin. Brigimadlin is taken as a film-coated tablet and is designed to be used as a monotherapy, meaning it is used alone without combining it with other treatments.

The purpose of this study is to evaluate how safe and tolerable brigimadlin is over a long period. Participants will continue taking brigimadlin and will be monitored for any side effects that may occur during the treatment. The study will look at how often these side effects happen, how severe they are, and how they relate to the treatment. This information will help understand the long-term effects of using brigimadlin in treating solid tumors.

Participants in this study will take brigimadlin orally, which means they will swallow the tablets. The study will last for a maximum of 60 days, during which the participants will have regular check-ups to monitor their health and any side effects they might experience. The study aims to ensure that brigimadlin is safe for long-term use in patients with solid tumors who have already been treated with this medication in a previous trial.

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

    Beginning of trial participation

    Upon joining the trial, ensure that you have provided a signed and dated, written informed consent form. This is necessary before any trial-specific procedures, sampling, or analyses can begin.

    Confirm that you meet all the inclusion criteria, such as ongoing treatment with brigimadlin or eligibility for crossover treatment from a previous trial.

  2. Step 2

    Treatment administration

    You will receive brigimadlin in the form of a film-coated tablet. This medication is taken orally.

    The dosage, frequency, and duration of administration will be determined based on the protocol of the trial you are participating in.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, you will be monitored for any treatment-emergent adverse events. These are side effects that may occur during the treatment period.

    Regular visits and laboratory tests will be scheduled to assess your health and the effects of the treatment.

  4. Step 4

    Use of birth control

    If you are a woman of childbearing potential or a man able to father a child, you must use two medically acceptable methods of birth control. This is required from the start of the trial until a specified period after the last dose of the medication.

  5. Step 5

    Completion of trial participation

    The trial is estimated to end on December 31, 2036. Your participation will continue until the trial concludes or until you meet the criteria for discontinuation.

Who can join the trial?

8 criteria

  • The patient is currently receiving or is eligible to switch to brigimadlin treatment in a related study.
  • The patient has signed and dated a written consent form, agreeing to participate in the study.
  • Women who can have children and men who can father a child must use two reliable methods of birth control, starting from the screening phase, during the study, and for a specified period after the last dose of the study drug.
  • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and adhere to lifestyle and study guidelines.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • Any side effects from previous cancer treatments must have improved to a mild level, except for hair loss and menstrual issues, which can be any level, and nerve damage, which must be mild or moderate.
  • For certain patients, they must be eligible to continue treatment as per the guidelines of the study they are currently in. If they are experiencing a delay due to side effects, they can still participate if they recover within the allowed time.
  • For other patients, they must be eligible to switch to this study directly from their current study, without receiving any other cancer treatments unless allowed by their current study.

Who cannot join the trial?

3 criteria

  • Patients who have not previously participated in another trial in the brigimadlin program cannot join this study.
  • Patients with medical conditions other than solid tumors are not eligible. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas.
  • Patients who are part of a vulnerable population are not allowed to participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Brigimadlin is a medication being studied for its long-term safety in patients with solid tumors. It is taken orally, which means it is swallowed in the form of a pill. The main goal of this trial is to see how safe brigimadlin is when used over a long period. Researchers are looking at any side effects that might happen while taking this medication, how often they occur, how serious they are, and whether they are related to the medication. This study is for patients who have already been part of another trial involving brigimadlin, and it aims to gather more information about its safety and tolerability.

What is already known about the treatment

Brigimadlin – Brigimadlin is administered orally and is currently being studied in clinical trials for its long-term safety in patients with solid tumors. It is not yet widely used in medicine, as it is still under investigation, but it has shown promise in previous studies. The main therapeutic indication for brigimadlin is the treatment of solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. At the molecular level, brigimadlin works by targeting specific pathways in cancer cells to inhibit their growth and survival. It is classified pharmacologically as an anti-cancer agent.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, solid tumors can invade nearby tissues and organs, potentially disrupting their normal function. The growth rate and behavior of solid tumors can vary widely depending on their type and location. Over time, they may spread to other parts of the body through the bloodstream or lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514177-21-00Protocol code1403-0032Estimated enrolment93 patientsSponsorBoehringer Ingelheim Espana S.A.

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