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)

Description

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.

Interventions

• BAY2927088 (Drug)
  tablet, oral

Eligibility criteria

Conditions

Locations

• 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 | Oncology — Halifax, Nova Scotia, Canada
• Princess Margaret Cancer Centre | Medical Oncology and Hematology — Toronto, Ontario, Canada
• Research Institute of the McGill University Health Centre | Women Health's Research Unit — 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
• Fudan University Shanghai Cancer Center - Oncology Department — Shanghai, Shanghai Municipality, China
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department — Hangzhou, Zhejiang, China
• Rigshospitalet Copenhagen University Hospital | Oncology Department — Copenhagen, Capital Region / Region Hovedstaden, Denmark
• Aarhus University Hospital | Oncology Department - Clinical Research Unit — Aarhus N, Central Denmark Region / Region Midtjylland, Denmark
• Odense University Hospital | Svendborg Sygehus - Oncology Department — Odense, Region of Southern Denmark / Region Syddanmark, Denmark
• Centre Hospitalier Lyon Sud - Service oncologie medicale — Pierre-Bénite, Auvergne-Rhône-Alpes, France
• CHU Brest - Hopital La Cavale Blanche - service oncologie medicale — Brest, Brittany Region, France
• Centre Oscar Lambret - Service Oncologie — Lille, Hauts-de-France, France
• Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale — Bordeaux, New Aquitaine, France
• ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP — Montpellier, Occitanie, France
• Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP) — Villejuif, Île-de-France Region, 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
• Seoul National University Hospital | Oncology — Jongno -Gu, Seoul, South Korea
• Severance Hospital | Oncology — Seoul, Seoul, South Korea
• Asan Medical Center | Oncology — Seoul, Seoul, South Korea
• Samsung Medical Center | Oncology — Seoul, Seoul, South Korea
• Institut Catala D'oncologia | Hospitalet | Oncologia — L'Hospitalet de Llobregat, Barcelona, Spain
• Instituto Oncologico Dr. Rosell S.L. | Oncologia — Barcelona, Spain
• Hospital Universitari Vall D Hebron | Oncologia Medica — Barcelona, Spain
• Clinica Universidad De Navarra | Madrid | Oncologia — Madrid, Spain
• Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica — Madrid, Spain
• Inselspital Bern - Universitätsklinik für Medizinische Onkologie — Bern, Canton of Bern, Switzerland
• Hopitaux Universitaires de Geneve - Oncology Department — Geneva, Canton of Geneva, Switzerland
• UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie — Zurich, Canton of Zurich, Switzerland