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

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 (sevabertinib) 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 breast, 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
RECRUITING
Birmingham
California
City of Hope - Duarte Cancer Center
RECRUITING
Duarte
Florida
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
RECRUITING
Fort Myers
Massachusetts
Dana-Farber Cancer Institute - Oncology Department
RECRUITING
Boston
Michigan
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
WITHDRAWN
Detroit
Profound Research -OMG - TriAtria Cancer Center
RECRUITING
Farmington Hills
Ohio
Cleveland Clinic - Oncology Department
RECRUITING
Cleveland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center - Texas Medical Center
RECRUITING
Houston
Washington
University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology
WITHDRAWN
Seattle
Wisconsin
UW Health - UW Carbone Cancer Center - Medical Oncology Clinic
RECRUITING
Madison
Other Locations
Australia
Blacktown Cancer & Haematology Centre
RECRUITING
Blacktown
ICON Cancer Centre - Southport
RECRUITING
Southport
Macquarie University Hospital - Oncology Department
RECRUITING
Sydney
Canada
Queen Elizabeth II Health Sciences Centre - Victoria General Site
RECRUITING
Halifax
McGill University Health Centre - Glen Site
RECRUITING
Montreal
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
RECRUITING
Toronto
China
Beijing Cancer Hospital - Oncology Department
RECRUITING
Beijing
Peking University First Hospital - Oncology Department
RECRUITING
Beijing
Hunan Cancer Hospital - Oncology Department
RECRUITING
Changsha
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
RECRUITING
Hangzhou
Fudan University Shanghai Cancer Center - Oncology Department
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University - Oncology Department
RECRUITING
Shanghai
Denmark
Aarhus University Hospital - Oncology Department
RECRUITING
Aarhus N
Rigshospitalet - Kræftbehandling
RECRUITING
Copenhagen Oe
Odense University Hospital - Oncology Department
RECRUITING
Odense C
France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
RECRUITING
Bordeaux
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
RECRUITING
Brest
Centre Oscar Lambret - Service Oncologie
RECRUITING
Lille
Institut du Cancer Montpellier (ICM)
NOT_YET_RECRUITING
Montpellier
Centre Hospitalier Lyon Sud - Service oncologie medicale
RECRUITING
Pierre-bénite
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
RECRUITING
Villejuif
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
RECRUITING
Milan
Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
NOT_YET_RECRUITING
Milan
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
RECRUITING
Roma
Japan
National Cancer Center Hospital
RECRUITING
Chuo-ku
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
RECRUITING
Kashiwa
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Aichi Cancer Center Hospital
RECRUITING
Nagoya
Hokkaido University Hospital
RECRUITING
Sapporo
Kindai University Hospital
RECRUITING
Sayama
Republic of Korea
Asan Medical Center - Oncology Department
RECRUITING
Seoul
Samsung Medical Center - Oncology Department
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System - Oncology Department
RECRUITING
Seoul
Spain
Hospital Quiron Dexeus - Oncologia
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron- Oncology Service
RECRUITING
Barcelona
Institut Catala d'Oncologia (ICO) -Oncology Department
RECRUITING
L'hospitalet De Llobregat
Clinica Universidad de Navarra-Oncology Service
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz- Oncology Service
RECRUITING
Madrid
Switzerland
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
RECRUITING
Bern
Hopitaux Universitaires de Geneve - Oncology Department
RECRUITING
Geneva
Univestitätsspital Zürich (USZ)
RECRUITING
Zurich
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2027-10-25
Participants
Target number of participants: 111
Treatments
Experimental: BAY2927088
Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria.~RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov

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