Advanced Solid Tumors study: BAY2927088
Official title 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)
ClinicalTrials.gov ID: NCT06760819
What this study is testing
What is BAY2927088?
This is an investigational oral tablet being studied as a potential treatment for advanced solid tumors with HER2 mutations. It is designed to block the abnormal HER2 protein to help stop cancer cell growth.
Also referred to as Sevabertinib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out how well the drug sevabertinib works and how safe it is for people with solid tumors that have a HER2 mutation.
- Who it's for
- The study is looking for adults aged 18 or older who have advanced solid tumors with a HER2 mutation, but not advanced non-small cell lung cancer.
- What's involved
- Participants will take a 20 mg sevabertinib pill by mouth. Doctors will perform imaging scans, heart tests, and blood and urine checks to monitor health and cancer spread.
- Time commitment
- Treatment continues in 3-week cycles until the cancer worsens, side effects occur, or the participant leaves the study.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma
- 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...
- Documented activating HER2 mutation
- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Fort Myers, Florida, United States
- Boston, Massachusetts, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Blacktown, New South Wales, Australia
- Sydney, New South Wales, Australia
- Toronto, Ontario, Canada
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Copenhagen, Capital Region / Region Hovedstaden, Denmark
- Odense, Region of Southern Denmark / Region Syddanmark, Denmark
- Pierre-Bénite, Auvergne-Rhône-Alpes, France
- Brest, Brittany Region, France
- Bordeaux, New Aquitaine, France
- Villejuif, Île-de-France Region, France
- Rome, Lazio, Italy
- Milan, Lombardy, Italy
- Nagoya, Aichi-ken, Japan
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Fort Myers, Florida, United States; Boston, Massachusetts, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States; Houston, Texas, United States and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.