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.
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
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.
54 sites in 11 countries
United States11 sites, 9 recruiting
- Not yet recruiting
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
- Recruiting
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, 02215
- Recruiting
Cleveland Clinic - Oncology Department
Cleveland, Ohio, 44195
- Withdrawn
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202
- Recruiting
City of Hope - Duarte Cancer Center
Duarte, California, 91010
- Not yet recruiting
Profound Research -OMG - TriAtria Cancer Center
Farmington Hills, Michigan, 48334
- 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
- Not yet recruiting
UW Health Carbone Cancer Center
Madison, Wisconsin, 53792
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Withdrawn
Gynecology Oncology clinic at UW Medical Center - Montlake
Seattle, Washington, 98195
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034
- Recruiting
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142
- Not yet 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
- Recruiting
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, Shanghai Municipality, 200000
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
France6 sites, 6 recruiting
- 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
- Not yet 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
- 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
Japan6 sites, 6 recruiting
- 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
Spain5 sites, 5 recruiting
- Not yet recruiting
Instituto Oncologico Dr. Rosell S.L. | Oncologia
Barcelona, 08028
- Recruiting
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, 08035
- Recruiting
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
- Not yet recruiting
Clinica Universidad De Navarra | Madrid | Oncologia
Madrid, 28027
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
Madrid, 28040
Italy4 sites, 4 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, 20133
- Not yet 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
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Roma, 00168
South Korea4 sites, 3 recruiting
- Active, not recruiting
Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, 03080
- Recruiting
Severance Hospital | Oncology
Seoul, Seoul, 03722
- Recruiting
Asan Medical Center | Oncology
Seoul, Seoul, 05505
- Recruiting
Samsung Medical Center | Oncology
Seoul, Seoul, 06351
Australia3 sites, 3 recruiting
- Recruiting
NSW Health - Blacktown Hospital
Blacktown, New South Wales, 2148
- Not yet recruiting
ICON Cancer Centre - Southport
Southport, Queensland, 4215
- Recruiting
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, 2109
Canada3 sites, 1 recruiting
- Withdrawn
Queen Elizabeth II Health Sciences Centre | Oncology
Halifax, Nova Scotia, B3H 2Y9
- Completed
Research Institute of the McGill University Health Centre | Women Health's Research Unit
Montreal, Quebec, H4A 3J1
- Recruiting
Princess Margaret Cancer Centre | Medical Oncology and Hematology
Toronto, Ontario, M5G 2C4
Denmark3 sites, 2 recruiting
- Withdrawn
Aarhus University Hospital | Oncology Department - Clinical Research Unit
Aarhus N, Central Denmark Region / Region Midtjylland, 8200
- Recruiting
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
Switzerland3 sites, 3 recruiting
- Not yet 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
- Recruiting
UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Canton of Zurich, 8091
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.
- Conditions
- Advanced Solid Tumors, HER2 Mutation
- 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 group | Role | What they receive |
|---|---|---|
| BAY2927088 | Experimental | 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 Receives: Drug: BAY2927088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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)
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
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
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
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
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
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
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
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
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)
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
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
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)
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)
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.
- First posted7 Jan 2025
- Study start13 Feb 2025
- Primary completion2 Feb 2029 (estimated)
- Study completion26 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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