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New pill targets HER2 cancers in promising trial

NCT ID NCT06760819

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 111 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    50 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aarhus University Hospital | Oncology Department - Clinical Research Unit

    NOT_YET_RECRUITING

    Aarhus N, Central Denmark Region / Region Midtjylland, 8200, Denmark

  • Aichi Cancer Center Hospital

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center | Oncology

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

    NOT_YET_RECRUITING

    Reggio Emilia, 42123, Italy

  • Beijing Cancer Hospital - Oncology Department

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

    WITHDRAWN

    Detroit, Michigan, 48202, United States

  • CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

    RECRUITING

    Brest, Brittany Region, 29200, France

  • Centre Hospitalier Lyon Sud - Service oncologie medicale

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

  • Centre Oscar Lambret - Service Oncologie

    NOT_YET_RECRUITING

    Lille, Hauts-de-France, 59000, France

  • City of Hope - Duarte Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic - Oncology Department

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad De Navarra | Madrid | Oncologia

    NOT_YET_RECRUITING

    Madrid, 28027, Spain

  • Dana-Farber Cancer Institute - Oncology Department

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    RECRUITING

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer Center - Oncology Department

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Gynecology Oncology clinic at UW Medical Center - Montlake

    WITHDRAWN

    Seattle, Washington, 98195, United States

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopitaux Universitaires de Geneve - Oncology Department

    NOT_YET_RECRUITING

    Geneva, 1205, Switzerland

  • Hospital Universitari Vall D Hebron | Oncologia Medica

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica

    RECRUITING

    Madrid, 28040, Spain

  • Hunan Cancer Hospital - Oncology Department

    NOT_YET_RECRUITING

    Changsha, Hunan, 410013, China

  • ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP

    NOT_YET_RECRUITING

    Montpellier, Occitanie, 34298, France

  • ICON Cancer Centre - Southport

    NOT_YET_RECRUITING

    Southport, Queensland, 4215, Australia

  • Inselspital Bern - Universitätsklinik für Medizinische Onkologie

    NOT_YET_RECRUITING

    Bern, 3010, Switzerland

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    RECRUITING

    Bordeaux, New Aquitaine, 33000, France

  • Institut Catala D'oncologia | Hospitalet | Oncologia

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)

    RECRUITING

    Villejuif, Île-de-France Region, 94805, France

  • Instituto Oncologico Dr. Rosell S.L. | Oncologia

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • Macquarie University Hospital - Oncology Department

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • NSW Health - Blacktown Hospital

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Odense University Hospital | Svendborg Sygehus - Oncology Department

    RECRUITING

    Odense, Region of Southern Denmark / Region Syddanmark, 5000, Denmark

  • Peking University First Hospital - Oncology Department

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Princess Margaret Cancer Centre | Medical Oncology and Hematology

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Profound Research -OMG - TriAtria Cancer Center

    NOT_YET_RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Queen Elizabeth II Health Sciences Centre | Oncology

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Research Institute of the McGill University Health Centre | Women Health's Research Unit

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    RECRUITING

    Copenhagen, Capital Region / Region Hovedstaden, 2100, Denmark

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center | Oncology

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital | Oncology

    ACTIVE_NOT_RECRUITING

    Jongno -Gu, Seoul, 03080, South Korea

  • Severance Hospital | Oncology

    RECRUITING

    Seoul, 03722, South Korea

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

  • UW Health Carbone Cancer Center

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53792, United States

  • UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie

    RECRUITING

    Zurich, 8091, Switzerland

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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