Actively Recruiting
A Phase 2 Open-label Study of Oral BAY 2927088 in Adults With Metastatic or Unresectable Solid Tumors Having HER2-activating Mutations
Led by Bayer · Updated on 2026-06-04
111
Participants Needed
54
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the treatment BAY2927088 (sevabertinib) in people aged 18 and older who have advanced solid tumors with HER2-activating mutations. These tumors include those in the colon, rectum, uterus, cervix, breast, bladder, biliary tract, and other solid tumors, excluding advanced non-small cell lung cancer (NSCLC). The study aims to understand how well BAY2927088 works and its safety in these patients. Participants will take 20 mg of BAY2927088 tablets by mouth twice daily in 3-week cycles. Treatment will continue until the cancer worsens, unacceptable side effects occur, or the participant chooses to leave the study. The trial includes about 111 participants and is an open-label, non-randomized Phase 2 study. During the trial, doctors will perform imaging scans to monitor cancer spread and will check heart health using echocardiogram, cardiac MRI, and electrocardiogram. Blood and urine samples, physical exams, and questionnaires about participants' well-being and medical issues will also be conducted. The main outcome measured is the objective response rate, with additional assessments including duration and time to response, disease control, progression-free survival, overall survival, adverse events, and quality of life over up to approximately three years.
CONDITIONS
Brief 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...
- Documented locally advanced, unresectable, or metastatic solid tumor with HER2-activating mutation (colorectal, biliary tract, bladder, cervical, endometrial, breast, or other solid tumors excluding NSCLC)
- Age 18 years or older or over the legal age of consent
- Prior standard therapy given or no satisfactory alternative treatments available
- At least one measurable lesion per RECIST 1.1 criteria
- Documented activating HER2 mutation
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive BAY2927088 tablets orally twice a day until disease progression, unacceptable toxicity, or withdrawal.
Regular visits for treatment monitoring and assessments during the treatment period
Duration - Up to 30 days after last treatment dose
Participants are monitored for safety and treatment outcomes after stopping BAY2927088.
1 to 2 visits depending on safety assessments
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 | Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
16
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
17
McGill University Health Centre - Glen Site - 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 Copenhagen University Hospital | Oncology Department
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
25
Aarhus University Hospital | Oncology Department - Clinical Research Unit
Aarhus N, Central Jutland, Denmark, 8200
Actively Recruiting
26
Odense University Hospital | Svendborg Sygehus - 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
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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