Treatment for solid tumors with HER2 mutations using BAY2927088 tablets
Official title: A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations
Run by Bayer · NCT06760819 · Data updated 2026-11-12
This study is testing if BAY2927088 tablets can help people with advanced solid tumors that have HER2 gene mutations feel better and manage their cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | sevabertinib |
| Locations | 54 sites (Birmingham, Alabama and 53 other locations) |
| Status | Recruiting |
| Started | February 13, 2025 |
| Main results expected | February 2, 2029 |
| Study ends | October 26, 2029 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06760819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with advanced solid tumors that have documented HER2 mutations.
✕Probably not a fit
Patients with primary non-small cell lung cancer or those who have previously received HER2 tyrosine kinase inhibitors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of BAY2927088 tablets in patients with advanced solid tumors that have mutations in the HER2 gene. The study focuses on various types of cancers, including colorectal, biliary tract, bladder, and cervical cancers, while excluding non-small cell lung cancer. Participants must have a documented HER2 mutation and measurable lesions to qualify for the trial. The goal is to understand how well this treatment can block the abnormal HER2 protein associated with tumor growth.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors harboring HER2 mutations.
How similar studies have gone: Other studies targeting HER2 mutations have shown promise, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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City of Hope - Duarte Cancer Center
Duarte, California, United States Recruiting -
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
Fort Myers, Florida, United States Recruiting -
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, United States Recruiting -
Cleveland Clinic - Oncology Department
Cleveland, Ohio, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, United States Recruiting
Show 44 more locations
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NSW Health - Blacktown Hospital
Blacktown, New South Wales, Australia Recruiting -
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, Australia Recruiting -
Princess Margaret Cancer Centre | Medical Oncology and Hematology
Toronto, Ontario, Canada Recruiting -
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, China Recruiting -
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, China Recruiting -
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, Shanghai Municipality, China Recruiting -
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Rigshospitalet Copenhagen University Hospital | Oncology Department
Copenhagen, Capital Region / Region Hovedstaden, Denmark Recruiting -
Odense University Hospital | Svendborg Sygehus - Oncology Department
Odense, Region of Southern Denmark / Region Syddanmark, Denmark Recruiting -
Centre Hospitalier Lyon Sud - Service oncologie medicale
Pierre-Bénite, Auvergne-Rhône-Alpes, France Recruiting -
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, Brittany Region, France Recruiting -
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, New Aquitaine, France Recruiting -
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif, Île-de-France Region, France Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome, Lazio, Italy Recruiting -
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Lombardy, Italy Recruiting -
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan Recruiting -
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
Kashiwa, Chiba, Japan Recruiting -
Hokkaido University Hospital
Sapporo, Hokkaido, Japan Recruiting -
Kindai University Hospital
Sakai, Osaka, Japan Recruiting -
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan Recruiting -
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan Recruiting -
Severance Hospital | Oncology
Seoul, South Korea Recruiting -
Asan Medical Center | Oncology
Seoul, South Korea Recruiting -
Samsung Medical Center | Oncology
Seoul, South Korea Recruiting -
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain Recruiting -
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, Catalonia, Spain Recruiting -
UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Switzerland Recruiting -
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States Not yet recruiting -
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, United States Withdrawn -
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, United States Withdrawn -
Gynecology Oncology clinic at UW Medical Center - Montlake
Seattle, Washington, United States Withdrawn -
UW Health Carbone Cancer Center
Madison, Wisconsin, United States Not yet recruiting -
ICON Cancer Centre - Southport
Southport, Queensland, Australia Not yet recruiting -
Queen Elizabeth II Health Sciences Centre | Oncology
Halifax, Nova Scotia, Canada Withdrawn -
Research Institute of the McGill University Health Centre | Women Health's Research Unit
Montreal, Quebec, Canada Withdrawn -
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, China Not yet recruiting -
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, China Not yet recruiting -
Aarhus University Hospital | Oncology Department - Clinical Research Unit
Aarhus N, Central Denmark Region / Region Midtjylland, Denmark Withdrawn -
Centre Oscar Lambret - Service Oncologie
Lille, Hauts-de-France, France Not yet recruiting -
ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
Montpellier, Occitanie, France Not yet recruiting -
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, Emilia-Romagna, Italy Not yet recruiting -
Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
Milan, Lombardy, Italy Not yet recruiting -
Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, South Korea Active not recruiting -
Instituto Oncologico Dr. Rosell S.L. | Oncologia
Barcelona, Catalonia, Spain Not yet recruiting
+4 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: 0018888422937
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.