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NCT06760819Recrutement en cours

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)

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Résumé

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.

Critères d'inclusion

• 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

Critères d'exclusion

• 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

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai
Statut
Recrutement en cours
Phase
Phase 2
Type d'étude
Interventionnelle
Pays
Suisse, France, Italie, États-Unis, Australie, Canada, Chine, Danemark, Japon, Corée du Sud, Espagne
Promoteur
Bayer(Industrie)
N° de protocole
22752
Pathologies
Advanced Solid Tumors, HER2 Mutation
Interventions
Médicament

Traitements évalués

  • BAY2927088

Lieux · 34

  • Zurich, SuisseUniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und HämatologieRecrute dans ce centre
  • Pierre-Bénite, FranceCentre Hospitalier Lyon Sud - Service oncologie medicaleRecrute dans ce centre
  • Brest, FranceCHU Brest - Hopital La Cavale Blanche - service oncologie medicaleRecrute dans ce centre
  • Bordeaux, FranceInstitut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicaleRecrute dans ce centre
  • Villejuif, FranceInstitut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)Recrute dans ce centre
  • Milan, ItalieFondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1Recrute dans ce centre
  • Roma, ItalieFondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia MedicaRecrute dans ce centre
  • Duarte, États-UnisCity of Hope - Duarte Cancer CenterRecrute dans ce centre
  • Fort Myers, États-UnisFlorida Cancer Specialists & Research Institute - Fort Myers Cancer Center - GladiolusRecrute dans ce centre
  • Boston, États-UnisDana-Farber Cancer Institute - Oncology DepartmentRecrute dans ce centre
  • Cleveland, États-UnisCleveland Clinic - Oncology DepartmentRecrute dans ce centre
  • Nashville, États-UnisSCRI Oncology PartnersRecrute dans ce centre
  • Houston, États-UnisThe University of Texas MD Anderson Cancer Center - Texas Medical CenterRecrute dans ce centre
  • Blacktown, AustralieNSW Health - Blacktown HospitalRecrute dans ce centre
  • Sydney, AustralieMacquarie University Hospital - Oncology DepartmentRecrute dans ce centre
  • Toronto, CanadaPrincess Margaret Cancer Centre | Medical Oncology and HematologyRecrute dans ce centre
  • Beijing, ChinePeking University First Hospital - Oncology DepartmentRecrute dans ce centre
  • Beijing, ChineBeijing Cancer Hospital - Oncology DepartmentRecrute dans ce centre
  • Shanghai, ChineFudan University Shanghai Cancer Center - Oncology DepartmentRecrute dans ce centre
  • Shanghai, ChineZhongshan Hospital, Fudan UniversityRecrute dans ce centre
  • Copenhagen, DanemarkRigshospitalet Copenhagen University Hospital | Oncology DepartmentRecrute dans ce centre
  • Odense, DanemarkOdense University Hospital | Svendborg Sygehus - Oncology DepartmentRecrute dans ce centre
  • Nagoya, JaponAichi Cancer Center HospitalRecrute dans ce centre
  • Kashiwa, JaponNational Cancer Center Hospital East (NCCHE) - Kashiwa CampusRecrute dans ce centre
  • Sapporo, JaponHokkaido University HospitalRecrute dans ce centre
  • Sakai, JaponKindai University HospitalRecrute dans ce centre
  • Chuo-ku, JaponNational Cancer Center HospitalRecrute dans ce centre
  • Koto-ku, JaponThe Cancer Institute Hospital of JFCRRecrute dans ce centre
  • Seoul, Corée du SudSeverance Hospital | OncologyRecrute dans ce centre
  • Seoul, Corée du SudAsan Medical Center | OncologyRecrute dans ce centre

Au total, dans le monde, 34 des 54 centres listés au registre recrutent ; les 20 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 2 octobre 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

+ 4 autres lieux

Autres identifiants

  • 2024-517419-62-00 · autre registre

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.