New pill targets HER2 cancers in promising trial
NCT ID NCT06760819
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This Phase 2 trial tests an oral drug called BAY 2927088 (sevabertinib) in about 111 adults with advanced solid tumors that have HER2 gene mutations. The drug aims to block the abnormal HER2 protein and stop cancer growth. Participants take a 20 mg tablet daily in 3-week cycles until their cancer worsens or side effects become too severe. The main goal is to see how many patients' tumors shrink or disappear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAY 2927088 (sevabertinib) tablet
- What this could lead to
- If successful, this could provide a new targeted treatment option for people with various HER2-mutated solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early Phase 2 study with only 111 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors in many patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 111 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumors are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
50 sites in 11 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital | Oncology Department - Clinical Research Unit
NOT_YET_RECRUITINGAarhus N, Central Denmark Region / Region Midtjylland, 8200, Denmark
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Aichi Cancer Center Hospital
RECRUITINGNagoya, Aichi-ken, 464-8681, Japan
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Asan Medical Center | Oncology
RECRUITINGSeoul, 05505, South Korea
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Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
NOT_YET_RECRUITINGReggio Emilia, 42123, Italy
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Beijing Cancer Hospital - Oncology Department
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
WITHDRAWNDetroit, Michigan, 48202, United States
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CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
RECRUITINGBrest, Brittany Region, 29200, France
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Centre Hospitalier Lyon Sud - Service oncologie medicale
RECRUITINGPierre-Bénite, Auvergne-Rhône-Alpes, 69310, France
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Centre Oscar Lambret - Service Oncologie
NOT_YET_RECRUITINGLille, Hauts-de-France, 59000, France
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City of Hope - Duarte Cancer Center
RECRUITINGDuarte, California, 91010, United States
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Cleveland Clinic - Oncology Department
RECRUITINGCleveland, Ohio, 44195, United States
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Clinica Universidad De Navarra | Madrid | Oncologia
NOT_YET_RECRUITINGMadrid, 28027, Spain
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Dana-Farber Cancer Institute - Oncology Department
RECRUITINGBoston, Massachusetts, 02215, United States
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Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
RECRUITINGFort Myers, Florida, 33908, United States
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Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
RECRUITINGRoma, 00168, Italy
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Fudan University Shanghai Cancer Center - Oncology Department
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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Gynecology Oncology clinic at UW Medical Center - Montlake
WITHDRAWNSeattle, Washington, 98195, United States
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Hokkaido University Hospital
RECRUITINGSapporo, Hokkaido, 060-8648, Japan
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Hopitaux Universitaires de Geneve - Oncology Department
NOT_YET_RECRUITINGGeneva, 1205, Switzerland
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Hospital Universitari Vall D Hebron | Oncologia Medica
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
RECRUITINGMadrid, 28040, Spain
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Hunan Cancer Hospital - Oncology Department
NOT_YET_RECRUITINGChangsha, Hunan, 410013, China
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ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
NOT_YET_RECRUITINGMontpellier, Occitanie, 34298, France
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ICON Cancer Centre - Southport
NOT_YET_RECRUITINGSouthport, Queensland, 4215, Australia
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Inselspital Bern - Universitätsklinik für Medizinische Onkologie
NOT_YET_RECRUITINGBern, 3010, Switzerland
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Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
RECRUITINGBordeaux, New Aquitaine, 33000, France
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Institut Catala D'oncologia | Hospitalet | Oncologia
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
RECRUITINGVillejuif, Île-de-France Region, 94805, France
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Instituto Oncologico Dr. Rosell S.L. | Oncologia
NOT_YET_RECRUITINGBarcelona, 08028, Spain
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Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
NOT_YET_RECRUITINGMilan, 20141, Italy
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Kindai University Hospital
RECRUITINGSakai, Osaka, 590-0197, Japan
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Macquarie University Hospital - Oncology Department
RECRUITINGSydney, New South Wales, 2109, Australia
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NSW Health - Blacktown Hospital
RECRUITINGBlacktown, New South Wales, 2148, Australia
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National Cancer Center Hospital
RECRUITINGChuo-ku, Tokyo, 104-0045, Japan
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National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
RECRUITINGKashiwa, Chiba, 277-8577, Japan
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Odense University Hospital | Svendborg Sygehus - Oncology Department
RECRUITINGOdense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark
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Peking University First Hospital - Oncology Department
RECRUITINGBeijing, Beijing Municipality, 100034, China
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Princess Margaret Cancer Centre | Medical Oncology and Hematology
RECRUITINGToronto, Ontario, M5G 2C4, Canada
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Profound Research -OMG - TriAtria Cancer Center
NOT_YET_RECRUITINGFarmington Hills, Michigan, 48334, United States
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Queen Elizabeth II Health Sciences Centre | Oncology
NOT_YET_RECRUITINGHalifax, Nova Scotia, B3H 2Y9, Canada
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Research Institute of the McGill University Health Centre | Women Health's Research Unit
COMPLETEDMontreal, Quebec, H4A 3J1, Canada
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Rigshospitalet Copenhagen University Hospital | Oncology Department
RECRUITINGCopenhagen, Capital Region / Region Hovedstaden, 2100, Denmark
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Samsung Medical Center | Oncology
RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital | Oncology
ACTIVE_NOT_RECRUITINGJongno -Gu, Seoul, 03080, South Korea
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Severance Hospital | Oncology
RECRUITINGSeoul, 03722, South Korea
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Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310016, China
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The Cancer Institute Hospital of JFCR
RECRUITINGKoto-ku, Tokyo, 135-8550, Japan
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The University of Texas MD Anderson Cancer Center - Texas Medical Center
RECRUITINGHouston, Texas, 77030, United States
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UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITINGBirmingham, Alabama, 35233, United States
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UW Health Carbone Cancer Center
NOT_YET_RECRUITINGMadison, Wisconsin, 53792, United States
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UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
RECRUITINGZurich, 8091, Switzerland
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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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