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Advanced Solid TumorsPhase 2panSOHONCT06760819

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)

A Phase 2 study testing BAY2927088 in people with Advanced Solid Tumors and HER2 Mutation, run by Bayer at 54 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, HER2 Mutation
What is being tested?
BAY2927088
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
54 sitesin 11 countries
Study dates
13 Feb 2025to 26 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

54 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

0018888422937

clinical-trials-contact@bayer.com

54 sites in 11 countries

United States11 sites, 9 recruiting

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

    Birmingham, Alabama, 35233

    Not yet recruiting

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215

    Recruiting

  • Cleveland Clinic - Oncology Department

    Cleveland, Ohio, 44195

    Recruiting

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

    Detroit, Michigan, 48202

    Withdrawn

  • City of Hope - Duarte Cancer Center

    Duarte, California, 91010

    Recruiting

  • Profound Research -OMG - TriAtria Cancer Center

    Farmington Hills, Michigan, 48334

    Not yet recruiting

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

    Fort Myers, Florida, 33908

    Recruiting

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

    Houston, Texas, 77030

    Recruiting

  • UW Health Carbone Cancer Center

    Madison, Wisconsin, 53792

    Not yet recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Gynecology Oncology clinic at UW Medical Center - Montlake

    Seattle, Washington, 98195

    Withdrawn

Other trials in United States

China6 sites, 6 recruiting

  • Peking University First Hospital - Oncology Department

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Hunan Cancer Hospital - Oncology Department

    Changsha, Hunan, 410013

    Not yet recruiting

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

    Hangzhou, Zhejiang, 310016

    Not yet recruiting

  • Fudan University Shanghai Cancer Center - Oncology Department

    Shanghai, Shanghai Municipality, 200000

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Recruiting

Other trials in China

France6 sites, 6 recruiting

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, New Aquitaine, 33000

    Recruiting

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

    Brest, Brittany Region, 29200

    Recruiting

  • Centre Oscar Lambret - Service Oncologie

    Lille, Hauts-de-France, 59000

    Not yet recruiting

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

    Montpellier, Occitanie, 34298

    Not yet recruiting

  • Centre Hospitalier Lyon Sud - Service oncologie medicale

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

    Recruiting

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

    Villejuif, Île-de-France Region, 94805

    Recruiting

Other trials in France

Japan6 sites, 6 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Recruiting

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

    Kashiwa, Chiba, 277-8577

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

Other trials in Japan

Spain5 sites, 5 recruiting

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

    Barcelona, 08028

    Not yet recruiting

  • Hospital Universitari Vall D Hebron | Oncologia Medica

    Barcelona, 08035

    Recruiting

  • Institut Catala D'oncologia | Hospitalet | Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

    Recruiting

  • Clinica Universidad De Navarra | Madrid | Oncologia

    Madrid, 28027

    Not yet recruiting

  • Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica

    Madrid, 28040

    Recruiting

Other trials in Spain

Italy4 sites, 4 recruiting

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

    Milan, 20133

    Recruiting

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

    Milan, 20141

    Not yet recruiting

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

    Reggio Emilia, 42123

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Roma, 00168

    Recruiting

Other trials in Italy

South Korea4 sites, 3 recruiting

  • Seoul National University Hospital | Oncology

    Jongno -Gu, Seoul, 03080

    Active, not recruiting

  • Severance Hospital | Oncology

    Seoul, Seoul, 03722

    Recruiting

  • Asan Medical Center | Oncology

    Seoul, Seoul, 05505

    Recruiting

  • Samsung Medical Center | Oncology

    Seoul, Seoul, 06351

    Recruiting

Other trials in South Korea

Australia3 sites, 3 recruiting

  • NSW Health - Blacktown Hospital

    Blacktown, New South Wales, 2148

    Recruiting

  • ICON Cancer Centre - Southport

    Southport, Queensland, 4215

    Not yet recruiting

  • Macquarie University Hospital - Oncology Department

    Sydney, New South Wales, 2109

    Recruiting

Other trials in Australia

Canada3 sites, 1 recruiting

  • Queen Elizabeth II Health Sciences Centre | Oncology

    Halifax, Nova Scotia, B3H 2Y9

    Withdrawn

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

    Montreal, Quebec, H4A 3J1

    Completed

  • Princess Margaret Cancer Centre | Medical Oncology and Hematology

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

Denmark3 sites, 2 recruiting

  • Aarhus University Hospital | Oncology Department - Clinical Research Unit

    Aarhus N, Central Denmark Region / Region Midtjylland, 8200

    Withdrawn

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    Copenhagen, Capital Region / Region Hovedstaden, 2100

    Recruiting

  • Odense University Hospital | Svendborg Sygehus - Oncology Department

    Odense, Region of Southern Denmark / Region Syddanmark, 5000

    Recruiting

Other trials in Denmark

Switzerland3 sites, 3 recruiting

  • Inselspital Bern - Universitätsklinik für Medizinische Onkologie

    Bern, Canton of Bern, 3010

    Not yet recruiting

  • Hopitaux Universitaires de Geneve - Oncology Department

    Geneva, Canton of Geneva, 1205

    Not yet recruiting

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

    Zurich, Canton of Zurich, 8091

    Recruiting

Other trials in Switzerland

About this study

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

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).

Read more

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.

Being tested
BAY2927088
Keywords
Colorectal cancer, CRC, Biliary tract cancer, BTC, Bladder cancer, Cervical cancer, Endometrial cancer, Sarcoma, Gastrointestinal stromal tumor, GIST, Breast cancer, Gastrointestinal cancer, GI cancer, Gastric cancer, Esophageal cancer, Gallbladder cancer, Pancreatic cancer, Ovarian Cancer, Salivary cancer, Ampullary cancer
Medical subject headings
Colorectal Neoplasms, Biliary Tract Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Sarcoma, Gastrointestinal Stromal Tumors, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2927088Drug

    Also called Sevabertinib

    tablet, oral

Study groups in NCT06760819
Study groupRoleWhat they receive
BAY2927088ExperimentalAdult 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
Receives: Drug: BAY2927088

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

  1. Duration of response (DOR) per RECIST 1.1 as assessed by BICR

    DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death from any cause, whichever occurs first. PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)

    Measured: 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

  2. Time to response (TTR) per RECIST 1.1 as assessed by BICR

    TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by BICR.

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)

    Measured: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)

  3. ORR per RECIST 1.1 as assessed by the investigator

    ORR is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per RECIST 1.1 by investigator.

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: 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

  4. Disease control rate (DCR) per RECIST 1.1 as assessed by BICR

    DCR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD), by the BICR per RECIST 1.1. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.

    Measured: 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

  5. DCR ≥12 weeks per RECIST 1.1 as assessed by BICR

    Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the BICR per RECIST 1.1.

    Measured: 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

  6. Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR

    Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the BICR, or death from any cause, whichever occurs first.

    Measured: 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

  7. Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator

    Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD, by the investigator per RECIST 1.1.

    Measured: 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

  8. DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator

    Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the investigator per RECIST 1.1.

    Measured: 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

  9. Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator

    Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first

    Measured: 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

  10. DOR per RECIST 1.1 as assessed by the investigator

    DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first.

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: 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. TTR per RECIST 1.1 as assessed by the investigator

    TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by the investigator.

    RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1

    Measured: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)

  12. Overall survival (OS)

    Defined as the time from the start of study treatment to the date of death from any cause.

    Measured: From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first

  13. Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE

    From first administration of study intervention up to 30 days after the last dose of study intervention.

    Measured: From first participant enrolled until up to 30 days after the last administration of study treatment

  14. Time to deterioration in EORTC QLQ-C30 physical functioning domain score

    The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the time to deterioration in the physical functioning domain score.

    EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

    Measured: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

  15. Change from baseline in EORTC QLQ-C30 physical functioning domain score

    The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in the physical functioning domain score.

    EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

    Measured: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

  16. Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)

    The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in global health status/QoL.

    EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

    Measured: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start13 Feb 2025
  3. Primary completion2 Feb 2029 (estimated)
  4. Study completion26 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760819
Sponsor's protocol ID
22752
Other IDs
2024-517419-62-00
Acronym
panSOHO
Status last verified
Oct 2026
First submitted
18 Dec 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY2927088 in people with Advanced Solid Tumors and HER2 Mutation, run by Bayer at 54 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, China, France, Japan, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (0018888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06760819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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panSOHO Clinical Trial NCT06760819 | AzTrials