Clinical trial Recruiting at 33 sites Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment111 (estimated)
SponsorBayer
Industry-sponsored
Drugs / interventionssevabertinib
Locations54 sites (Birmingham, Alabama and 53 other locations)
StatusRecruiting
StartedFebruary 13, 2025
Main results expectedFebruary 2, 2029
Study endsOctober 26, 2029
Registry record updatedNovember 4, 2026
Trial IDNCT06760819 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

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  • Sevabertinib in HER2-mutant Advanced NSCLC: Real-world Outcomes

    This study looks at how Sevabertinib works in real-world adults with HER2-mutant advanced NSCLC who have had prior treatment, to see its effectiveness, safety, and impact on quality of life.

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  • AK157D1 injection for advanced solid tumors

    A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

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  • ABBV-253 in adults with advanced solid tumors

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  • MK-2010 alone or with other treatments for advanced solid tumors

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.