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Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

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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 for people with advanced solid tumors that have a specific change in their genes known as a HER2 mutation. The treatment being tested is a medication called BAY 2927088, which is taken as a coated tablet. This medication is a type of drug known as a reversible tyrosine kinase inhibitor, which works by blocking certain proteins that help cancer cells grow.

The purpose of the study is to learn more about how well the treatment works and how safe it is for participants. The study will involve taking the medication by mouth for a period of up to 36 months. Participants will be monitored regularly to see how their tumors respond to the treatment and to check for any side effects. The study will also look at how long the treatment keeps the disease under control and how it affects the overall health and quality of life of the participants.

Participants in the study will have regular check-ups and tests to track their progress. These tests will help researchers understand the effectiveness of the treatment and any potential risks. The study aims to provide valuable information that could lead to better treatment options for people with these types of tumors in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a HER2 mutation and ensuring the tumor is either metastatic or cannot be surgically removed.

    Eligibility criteria include being 18 years or older and having previously received standard therapy for the specific type and stage of cancer, or having no satisfactory alternative treatments.

  2. Step 2

    Treatment initiation

    The treatment involves taking BAY 2927088 tablets orally. The specific dosage and frequency are determined by the study protocol and the healthcare provider overseeing the trial.

    The medication is a reversible tyrosine kinase inhibitor, which targets specific mutations in the cancer cells.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the response to the treatment. This includes imaging tests to measure tumor size and determine the objective response rate (ORR).

    The duration of response and time to response are evaluated using standardized criteria.

  4. Step 4

    Safety assessments

    Safety assessments are performed to monitor for any adverse effects from the treatment. This includes tracking any treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs).

    The severity of any side effects is categorized, and adjustments to the treatment may be made if necessary.

  5. Step 5

    Quality of life evaluations

    Quality of life is assessed using a standardized questionnaire, focusing on physical functioning and overall health status.

    Changes from baseline in these areas are monitored throughout the trial.

  6. Step 6

    Completion of trial

    The trial is estimated to conclude by October 25, 2027. Upon completion, final assessments are conducted to evaluate the overall survival and long-term effects of the treatment.

    Participants may receive follow-up care as determined by the healthcare provider.

Who can join the trial?

5 criteria

  • The patient must have a type of cancer called a solid tumor, which is advanced and cannot be removed by surgery. This includes cancers like colorectal cancer, biliary tract cancer, bladder and urinary tract cancer, cervical cancer, endometrial cancer, and other solid tumors, but not lung cancer.
  • The patient must be at least 18 years old or older, depending on the legal age of consent in their area.
  • The patient should have already tried standard treatments suitable for their type and stage of cancer, or there should be no other satisfactory treatment options available.
  • The patient must have a specific change in their cancer called an activating HER2 mutation. This is a change in the HER2 gene that can affect how the cancer grows.
  • The patient must have at least one cancer area that can be measured and tracked during the study. This is determined by a set of guidelines called RECIST 1.1 criteria, which help doctors measure how the cancer responds to treatment.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that forms in solid organs or tissues and has spread to other parts of the body.
  • Patients without a HER2 mutation cannot participate. A HER2 mutation is a change in a specific gene that can affect how cancer grows.
  • Patients who are not within the specified age range cannot participate. The age range includes both children and adults.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that could interfere with the study cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have certain allergies or reactions to the study medication cannot participate.
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Investigated drugs

BAY 2927088 is an oral medication being studied for its effectiveness and safety in treating certain types of advanced solid tumors. It works by inhibiting specific proteins known as tyrosine kinases, which are involved in the growth and spread of cancer cells. This medication is being tested in patients whose tumors have specific mutations that activate a protein called HER2, which can promote cancer progression. The goal of the study is to see how well this medication can reduce the size of tumors or stop them from growing.

What is already known about the treatment

BAY 2927088 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors with HER2 mutations. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication is for patients with metastatic or unresectable solid tumors that have HER2-activating mutations. BAY 2927088 works as a reversible tyrosine kinase inhibitor, targeting specific enzymes involved in the growth and spread of cancer cells. It is classified pharmacologically as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

  • Advanced Solid Tumors

    These are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to an advanced stage. At this stage, the tumors have typically spread beyond their original location to other parts of the body. The progression of these tumors can vary depending on the type and location of the cancer, as well as individual patient factors. They often grow and spread more aggressively, making them more challenging to manage. The symptoms and impact on the body can be significant, affecting various bodily functions and overall health.

  • HER2 Mutation

    This refers to a genetic alteration in the human epidermal growth factor receptor 2 (HER2) gene, which can lead to the overproduction of the HER2 protein. This protein is involved in cell growth and division, and its overexpression can cause cells to grow uncontrollably, contributing to the development of certain types of cancer, such as breast and gastric cancers. The mutation can result in more aggressive tumor behavior and influence the progression of the disease. It is a significant factor in determining the characteristics and potential treatment approaches for the cancer. The presence of a HER2 mutation can affect the growth rate and spread of the cancer cells.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517419-62-00Protocol code22752Estimated enrolment111 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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