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) (NCT06760819)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital — Birmingham, Alabama
- City of Hope - Duarte Cancer Center — Duarte, California
- Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus — Fort Myers, Florida
- Dana-Farber Cancer Institute - Oncology Department — Boston, Massachusetts
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit — Detroit, Michigan
- Profound Research -OMG - TriAtria Cancer Center — Farmington Hills, Michigan
- Cleveland Clinic - Oncology Department — Cleveland, Ohio
- SCRI Oncology Partners — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center - Texas Medical Center — Houston, Texas
- Gynecology Oncology clinic at UW Medical Center - Montlake — Seattle, Washington
- UW Health Carbone Cancer Center — Madison, Wisconsin
- NSW Health - Blacktown Hospital — Blacktown, New South Wales
- Macquarie University Hospital - Oncology Department — Sydney, New South Wales
- ICON Cancer Centre - Southport — Southport, Queensland
- Queen Elizabeth II Health Sciences Centre | Oncology — Halifax, Nova Scotia
- Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology — Toronto, Ontario
- McGill University Health Centre - Glen Site - Women Health's Research Unit — Montreal, Quebec
- Peking University First Hospital - Oncology Department — Beijing, Beijing Municipality
- Beijing Cancer Hospital - Oncology Department — Beijing, Beijing Municipality
- Hunan Cancer Hospital - Oncology Department — Changsha, Hunan
- Fudan University Shanghai Cancer Center - Oncology Department — Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department — Hangzhou, Zhejiang
- Rigshospitalet Copenhagen University Hospital | Oncology Department — Copenhagen, Capital Region
- Aarhus University Hospital | Oncology Department - Clinical Research Unit — Aarhus N, Central Jutland
📞 Contact the Study Coordinator
Phone: (888) 842-2937
Email: clinical-trials-contact@bayer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumors
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- A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer — Orange, California
- QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations — Denver, Colorado
- A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors — Denver, Colorado
- A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer — Scottsdale, Arizona
- A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations — Los Angeles, California
Explore by condition: All Advanced Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.