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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bayer
Study ID
NCT06760819
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • HER2 Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BAY2927088 — DRUG
    tablet, oral

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Jun 2026
Primary completion
Feb 3, 2027
Completion
Oct 25, 2027

Study Design

Enrollment
111 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB HospitalBirminghamAlabama35233-
City of Hope - Duarte Cancer CenterDuarteCalifornia91010-
Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - GladiolusFort MyersFlorida33908-
Dana-Farber Cancer Institute - Oncology DepartmentBostonMassachusetts02215-
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - DetroitDetroitMichigan48202-
Profound Research -OMG - TriAtria Cancer CenterFarmington HillsMichigan48334-
Cleveland Clinic - Oncology DepartmentClevelandOhio44195-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer Center - Texas Medical CenterHoustonTexas77030-
Gynecology Oncology clinic at UW Medical Center - MontlakeSeattleWashington98195-
UW Health Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital· Birmingham, ALCity of Hope - Duarte Cancer Center· Duarte, CAFlorida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus· Fort Myers, FLDana-Farber Cancer Institute - Oncology Department· Boston, MABrigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit· Detroit, MIProfound Research -OMG - TriAtria Cancer Center· Farmington Hills, MI

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