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NCT06760819 · ClinicalTrials.gov registry record · Phase 2
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 of Advanced Solid Tumors and HER2 Mutation, sponsored by Bayer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
- 20
- Study locations
NCT06760819 is a Phase 2 study of Advanced Solid Tumors and HER2 Mutation that is actively recruiting participants, run by Bayer. The registered enrollment target is 111 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT06760819, a Phase 2 study of Advanced Solid Tumors and HER2 Mutation, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG BAY2927088
Study Locations (20)
Michigan
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit - Detroit
- Profound Research -OMG - TriAtria Cancer Center - Farmington Hills
New South Wales
- NSW Health - Blacktown Hospital - Blacktown
- Macquarie University Hospital - Oncology Department - Sydney
Beijing Municipality
- Peking University First Hospital - Oncology Department - Beijing
- Beijing Cancer Hospital - Oncology Department - Beijing
Alabama
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital - Birmingham
California
- City of Hope - Duarte Cancer Center - Duarte
Florida
- Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus - Fort Myers
Massachusetts
- Dana-Farber Cancer Institute - Oncology Department - Boston
Ohio
- Cleveland Clinic - Oncology Department - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2027-10-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06760819
The ClinicalTrials.gov registry entry for NCT06760819 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which BAY2927088 is the first listed.
NCT06760819 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Michigan, New South Wales, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT06760819 about?
NCT06760819 is a clinical study titled "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)". 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 wel...
What is the current status of trial NCT06760819?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2025-02-13. Estimated completion is 2027-10-25.
What conditions does trial NCT06760819 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, HER2 Mutation.
What interventions are being tested in trial NCT06760819?
The interventions under investigation include: BAY2927088 (DRUG).
Who is sponsoring clinical trial NCT06760819?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06760819 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.