A Study to Learn More About How Well Treatment With BAY2927088 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)

Last updated: April 29, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

BAY2927088

Clinical Study ID

NCT06760819
22752
2024-517419-62-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).

Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.

The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.

The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.

During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented histologically or cytologically confirmed locally advanced, unresectableor metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer;bladder and urothelial tract cancer; cervical cancer; endometrial cancer; othersolid 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 typeand 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 1.1criteria

Exclusion

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

Study Design

Total Participants: 111
Treatment Group(s): 1
Primary Treatment: BAY2927088
Phase: 2
Study Start date:
February 13, 2025
Estimated Completion Date:
October 25, 2027

Connect with a study center

  • Blacktown Cancer & Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Macquarie University Hospital

    Sydney, New South Wales 2109
    Australia

    Site Not Available

  • ICON Cancer Centre - Southport

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Nova Scotia Health

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre - Victoria General Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • McGill University Health Centre - Glen Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Xuhui District, Shanghai 200032
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200000
    China

    Site Not Available

  • Aarhus University Hospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Rigshospitalet - Kræftbehandling

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Rigshospitalet - Kræftbehandling

    Copenhagen OE, 2100
    Denmark

    Active - Recruiting

  • Odense University Hospital - Oncology Department

    Odense C, 5000
    Denmark

    Site Not Available

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, 33000
    France

    Active - Recruiting

  • Institut Bergonié - Unicancer Nouvelle Aquitaine - Service Oncologie médicale

    Bordeaux, 33000
    France

    Site Not Available

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

    Brest, 29200
    France

    Active - Recruiting

  • Hôpital La Cavale Blanche - CHU de Brest - Service oncologie médicale

    Brest, 29200
    France

    Site Not Available

  • Centre Oscar Lambret - Service Oncologie

    Lille, 59000
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud - Service oncologie medicale

    Pierre-Benite, 69310
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud - Service oncologie médicale

    Pierre-Benite, 69310
    France

    Site Not Available

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

    Villejuif Cedex, 94805
    France

    Site Not Available

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

    Milano, 20133
    Italy

    Site Not Available

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

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Roma, 00168
    Italy

    Site Not Available

  • Aichi Cancer Center Hospital

    Nagoya, Aichi 464-8681
    Japan

    Site Not Available

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

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo 135-8550
    Japan

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 3080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location

    Hospitalet de Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

    Madrid, Navarra 28027
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

    Barcelona, 8035
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz (Clinica de la Concepcion)

    Madrid, 28040
    Spain

    Site Not Available

  • Inselspital Bern - Universitätsklinik für Medizinische Onkologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve

    Genève, 1205
    Switzerland

    Site Not Available

  • Univestitätsspital Zürich (USZ)

    Zürich, 8091
    Switzerland

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • City of Hope - Duarte Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center

    Fort Myers, Florida 33908-4156
    United States

    Site Not Available

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

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

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

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Profound Research LLC

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute (SCRI) - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4000
    United States

    Active - Recruiting

  • University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology

    Seattle, Washington 98195-0001
    United States

    Site Not Available

  • UW Health - UW Carbone Cancer Center - Medical Oncology Clinic

    Madison, Wisconsin 53792
    United States

    Site Not Available

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