Study on the Effectiveness and Safety of BAY2927088 Tablets for Treating Solid Tumors with HER2 Mutations
Sponsor: Bayer
ClinicalTrials ID:NCT06760819
This clinical trial is testing a new treatment, BAY2927088, to see how well it works and how safe it is for people with solid tumors that have specific HER2 mutations. The study includes various types of solid tumors, except for advanced non-small cell lung cancer.
Patient Parameters
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Program Overview
Researchers are conducting a study to find better treatments for people with solid tumors that have mutations in the HER2 gene. These mutations cause an abnormal HER2 protein that leads to increased cancer cell growth. The study drug, BAY2927088, aims to block this abnormal protein and potentially stop the cancer from spreading. The trial involves about 111 participants, all taking 20 mg of BAY2927088 tablets. Participants will take the medication in 3-week cycles, continuing until their cancer worsens, they experience medical issues, or they choose to leave the trial. Throughout the study, doctors will monitor the cancer's spread with imaging scans, check heart health, and conduct blood and urine tests, along with physical exams. They will also ask participants about their well-being and any health problems.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor cancer, such as colorectal, biliary tract, bladder, cervical, or endometrial cancer, but not non-small cell lung cancer (NSCLC).
- Be 18 years or older.
- Have already tried standard treatments for their cancer type and stage, or have no other satisfactory treatment options.
- Have a documented HER2 mutation.
- Have at least one measurable tumor that can be tracked during the study.
Exclusion Criteria
- Have a primary diagnosis of non-small cell lung cancer (NSCLC).
- Have previously been treated with a HER2 tyrosine kinase inhibitor (TKI).
- Have active cancer that has spread to the brain.
- Have uncontrolled severe illnesses.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35233 | Birmingham | Alabama |
| City of Hope - Duarte Cancer Center | 91010 | Duarte | California |
| Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus | 33908 | Fort Myers | Florida |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit | 48202 | Detroit | Michigan |
| Profound Research LLC | 48334 | Farmington Hills | Michigan |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| Sarah Cannon Research Institute (SCRI) - Nashville | 37203 | Nashville | Tennessee |
| University of Texas MD Anderson Cancer Center | 77030-4000 | Houston | Texas |
| University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology | 98195-0001 | Seattle | Washington |
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