A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) 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)
panSOHO
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
2 other identifiers
interventional
111
11 countries
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2025
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2024
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedStudy Start
First participant enrolled
February 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 25, 2027
May 7, 2026
May 1, 2026
2 years
December 18, 2024
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \<10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Secondary Outcomes (16)
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Time to response (TTR) per RECIST 1.1 as assessed by BICR
From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
ORR per RECIST 1.1 as assessed by the investigator
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
- +11 more secondary outcomes
Study Arms (1)
BAY2927088
EXPERIMENTALAdult 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (54)
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
City of Hope - Duarte Cancer Center
Duarte, California, 91010, United States
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
Fort Myers, Florida, 33908, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, 02215, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202, United States
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, 48334, United States
Cleveland Clinic - Oncology Department
Cleveland, Ohio, 44195, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, 77030, United States
Gynecology Oncology clinic at UW Medical Center - Montlake
Seattle, Washington, 98195, United States
UW Health Carbone Cancer Center
Madison, Wisconsin, 53792, United States
NSW Health - Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, 2109, Australia
ICON Cancer Centre - Southport
Southport, Queensland, 4215, Australia
Queen Elizabeth II Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 1V7, Canada
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology
Toronto, Ontario, M5G 2C4, Canada
Women Health's Research Unit
Montreal, Quebec, H4A 3J1, Canada
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034, China
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142, China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, 410013, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, 310016, China
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, 200000, China
Rigshospitalet - Kræftbehandling
Copenhagen, Capital Region, 2100, Denmark
Aarhus University Hospital - Oncology Department
Aarhus N, Central Jutland, 8200, Denmark
Odense University Hospital - Oncology Department
Odense, Region Syddanmark, 5000, Denmark
Centre Hospitalier Lyon Sud - Service oncologie medicale
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
Brest, Brittany Region, 29200, France
Centre Oscar Lambret - Service Oncologie
Lille, Hauts-de-France, 59000, France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, New Aquitaine, 33000, France
ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
Montpellier, Occitanie, 34298, France
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif, Île-de-France Region, 94805, France
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, 20133, Italy
Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
Milan, 20141, Italy
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, 42123, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, 00168, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center | Oncology
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Samsung Medical Center - Oncology Department
Seoul, 06351, South Korea
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Clinica Universidad De Navarra | Madrid | Oncologia
Madrid, Navarre, 28027, Spain
Instituto Oncologico Dr. Rosell S.L. | Oncologia
Barcelona, 08028, Spain
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
Madrid, 28040, Spain
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
Bern, 3010, Switzerland
Hopitaux Universitaires de Geneve - Oncology Department
Geneva, 1205, Switzerland
Univestitätsspital Zürich (USZ)
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 18, 2024
First Posted
January 7, 2025
Study Start
February 13, 2025
Primary Completion (Estimated)
February 3, 2027
Study Completion (Estimated)
October 25, 2027
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.