Actively Recruiting
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)
Led by Bayer · Updated on 2026-05-07
111
Participants Needed
54
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumor (excluding NSCLC)
- Age 18 years or older
- Prior standard therapy received or no satisfactory alternative treatments available
- Documented activating HER2 mutation
- At least one measurable lesion per RECIST 1.1 criteria
You will not qualify if you...
- Diagnosis of non-small cell lung cancer (NSCLC)
- Prior treatment with HER2 tyrosine kinase inhibitors
- Active brain metastases
- Uncontrolled, severe, intercurrent illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope - Duarte Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
Fort Myers, Florida, United States, 33908
Actively Recruiting
4
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, United States, 48202
Withdrawn
6
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
7
Cleveland Clinic - Oncology Department
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Gynecology Oncology clinic at UW Medical Center - Montlake
Seattle, Washington, United States, 98195
Withdrawn
11
UW Health Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
12
NSW Health - Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
13
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, Australia, 2109
Actively Recruiting
14
ICON Cancer Centre - Southport
Southport, Queensland, Australia, 4215
Actively Recruiting
15
Queen Elizabeth II Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
16
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
17
Women Health's Research Unit
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
18
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
19
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
20
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, China, 410013
Actively Recruiting
21
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
22
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
23
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, China, 200000
Actively Recruiting
24
Rigshospitalet - Kræftbehandling
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
25
Aarhus University Hospital - Oncology Department
Aarhus N, Central Jutland, Denmark, 8200
Actively Recruiting
26
Odense University Hospital - Oncology Department
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
27
Centre Hospitalier Lyon Sud - Service oncologie medicale
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
Actively Recruiting
28
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, Brittany Region, France, 29200
Actively Recruiting
29
Centre Oscar Lambret - Service Oncologie
Lille, Hauts-de-France, France, 59000
Actively Recruiting
30
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, New Aquitaine, France, 33000
Actively Recruiting
31
ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
Montpellier, Occitanie, France, 34298
Actively Recruiting
32
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
33
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Italy, 20133
Actively Recruiting
34
Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
Milan, Italy, 20141
Actively Recruiting
35
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, Italy, 42123
Actively Recruiting
36
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, Italy, 00168
Actively Recruiting
37
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
38
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
39
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
40
Kindai University Hospital
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
41
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
42
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
43
Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
44
Asan Medical Center | Oncology
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
45
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
46
Samsung Medical Center - Oncology Department
Seoul, South Korea, 06351
Actively Recruiting
47
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
48
Clinica Universidad De Navarra | Madrid | Oncologia
Madrid, Navarre, Spain, 28027
Actively Recruiting
49
Instituto Oncologico Dr. Rosell S.L. | Oncologia
Barcelona, Spain, 08028
Actively Recruiting
50
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, Spain, 08035
Actively Recruiting
51
Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
Madrid, Spain, 28040
Actively Recruiting
52
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
Bern, Switzerland, 3010
Actively Recruiting
53
Hopitaux Universitaires de Geneve - Oncology Department
Geneva, Switzerland, 1205
Actively Recruiting
54
Univestitätsspital Zürich (USZ)
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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