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)

Plain-language summary

This study looks at how well and how safely Sevabertinib (BAY 2927088) tablets work in patients whose solid tumors carry a HER2 mutation. It enrolls adults aged 18 and older with locally advanced, unresectable, or metastatic solid tumors and a confirmed activating HER2 mutation (non-small cell lung cancer is excluded). The study is Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Bayer

Intervention

BAY2927088

Start date

2/13/2025

Estimated completion

10/25/2027

Countries

United States, Australia, Canada, China, Denmark, France, Italy, Japan, South Korea, Spain, Switzerland

Related genes

Locations

• Birmingham, United States
• Duarte, United States
• Fort Myers, United States
• Boston, United States
• Detroit, United States
• Farmington Hills, United States
• Cleveland, United States
• Nashville, United States
• Houston, United States
• Seattle, United States
• Madison, United States
• Blacktown, Australia
• Sydney, Australia
• Southport, Australia
• Halifax, Canada
• Toronto, Canada
• Montreal, Canada
• Beijing, China
• Beijing, China
• Changsha, China
• Shanghai, China
• Hangzhou, China
• Shanghai, China
• Copenhagen, Denmark
• Aarhus N, Denmark
• Odense, Denmark
• Pierre-Bénite, France
• Brest, France
• Lille, France
• Bordeaux, France
• Montpellier, France
• Villejuif, France
• Milan, Italy
• Milan, Italy
• Reggio Emilia, Italy
• Roma, Italy
• Nagoya, Japan
• Kashiwa, Japan
• Sapporo, Japan
• Sakai, Japan

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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