NCT06760819Recruiting
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Summary
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
Inclusion criteria
• Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC) • Participant must be ≥18 years of age or over the legal age of consent • Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments • Documented activating HER2 mutation • At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
Exclusion criteria
• Primary diagnosis of non-small cell lung cancer (NSCLC) • Prior treatment with a HER2 tyrosine kinase inhibitor (TKI) • Active brain metastases • Uncontrolled, severe, intercurrent illness
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Italy, United States, Australia, Canada, China, Denmark, Japan, South Korea, Spain
- Sponsor
- Bayer(Industry)
- Protocol no.
- 22752
- Conditions
- Advanced Solid Tumors, HER2 Mutation
- Interventions
- Drug
Treatments studied
- BAY2927088
Locations · 34
- Zurich, SwitzerlandUniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und HämatologieRecruiting at this site
- Pierre-Bénite, FranceCentre Hospitalier Lyon Sud - Service oncologie medicaleRecruiting at this site
- Brest, FranceCHU Brest - Hopital La Cavale Blanche - service oncologie medicaleRecruiting at this site
- Bordeaux, FranceInstitut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicaleRecruiting at this site
- Villejuif, FranceInstitut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)Recruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1Recruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia MedicaRecruiting at this site
- Duarte, United StatesCity of Hope - Duarte Cancer CenterRecruiting at this site
- Fort Myers, United StatesFlorida Cancer Specialists & Research Institute - Fort Myers Cancer Center - GladiolusRecruiting at this site
- Boston, United StatesDana-Farber Cancer Institute - Oncology DepartmentRecruiting at this site
- Cleveland, United StatesCleveland Clinic - Oncology DepartmentRecruiting at this site
- Nashville, United StatesSCRI Oncology PartnersRecruiting at this site
- Houston, United StatesThe University of Texas MD Anderson Cancer Center - Texas Medical CenterRecruiting at this site
- Blacktown, AustraliaNSW Health - Blacktown HospitalRecruiting at this site
- Sydney, AustraliaMacquarie University Hospital - Oncology DepartmentRecruiting at this site
- Toronto, CanadaPrincess Margaret Cancer Centre | Medical Oncology and HematologyRecruiting at this site
- Beijing, ChinaPeking University First Hospital - Oncology DepartmentRecruiting at this site
- Beijing, ChinaBeijing Cancer Hospital - Oncology DepartmentRecruiting at this site
- Shanghai, ChinaFudan University Shanghai Cancer Center - Oncology DepartmentRecruiting at this site
- Shanghai, ChinaZhongshan Hospital, Fudan UniversityRecruiting at this site
- Copenhagen, DenmarkRigshospitalet Copenhagen University Hospital | Oncology DepartmentRecruiting at this site
- Odense, DenmarkOdense University Hospital | Svendborg Sygehus - Oncology DepartmentRecruiting at this site
- Nagoya, JapanAichi Cancer Center HospitalRecruiting at this site
- Kashiwa, JapanNational Cancer Center Hospital East (NCCHE) - Kashiwa CampusRecruiting at this site
- Sapporo, JapanHokkaido University HospitalRecruiting at this site
- Sakai, JapanKindai University HospitalRecruiting at this site
- Chuo-ku, JapanNational Cancer Center HospitalRecruiting at this site
- Koto-ku, JapanThe Cancer Institute Hospital of JFCRRecruiting at this site
- Seoul, South KoreaSeverance Hospital | OncologyRecruiting at this site
- Seoul, South KoreaAsan Medical Center | OncologyRecruiting at this site
In total, worldwide, 34 of the 54 sites listed in the registry are recruiting; the other 20 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 2, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 4 more locations
Other identifiers
- 2024-517419-62-00 · other registry
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.