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)
NCT ID: NCT06760819
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
111 participants
INTERVENTIONAL
2025-02-13
2027-10-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAY2927088
Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day
BAY2927088
tablet, oral
Interventions
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BAY2927088
tablet, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
* Active brain metastases
* Uncontrolled, severe, intercurrent illness
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
City of Hope - Duarte Cancer Center
Duarte, California, United States
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
Fort Myers, Florida, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, United States
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, United States
Cleveland Clinic - Oncology Department
Cleveland, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, United States
Gynecology Oncology clinic at UW Medical Center - Montlake
Seattle, Washington, United States
UW Health Carbone Cancer Center
Madison, Wisconsin, United States
NSW Health - Blacktown Hospital
Blacktown, New South Wales, Australia
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, Australia
ICON Cancer Centre - Southport
Southport, Queensland, Australia
Queen Elizabeth II Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, China
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, China
Zhongshan Hospital, Fudan University - Oncology Department
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, , China
Aarhus University Hospital - Oncology Department
Aarhus N, , Denmark
Rigshospitalet - Kræftbehandling
Copenhagen, , Denmark
Odense University Hospital - Oncology Department
Odense C, , Denmark
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, , France
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, , France
Centre Oscar Lambret - Service Oncologie
Lille, , France
ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
Montpellier, , France
Centre Hospitalier Lyon Sud - Service oncologie medicale
Pierre-Bénite, , France
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif, , France
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, , Italy
Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
Milan, , Italy
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kindai University Hospital
Sakai, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center | Oncology
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center - Oncology Department
Seoul, , South Korea
Institut Catala D'oncologia | Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad De Navarra | Oncologia Medica
Madrid, Navarre, Spain
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
Barcelona, , Spain
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
Madrid, , Spain
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
Bern, , Switzerland
Hopitaux Universitaires de Geneve - Oncology Department
Geneva, , Switzerland
Univestitätsspital Zürich (USZ)
Zurich, , Switzerland
Countries
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Central Contacts
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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2024-517419-62-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
22752
Identifier Type: -
Identifier Source: org_study_id
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