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)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• BAY2927088 (Drug): tablet, oral

Non Randomized · Single Group · masking: None

Main goals

• Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR (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)

Other goals

• Duration of response (DOR) per RECIST 1.1 as assessed by BICR
• Time to response (TTR) per RECIST 1.1 as assessed by BICR
• ORR per RECIST 1.1 as assessed by the investigator
• Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
• DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
• Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
• Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
• DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
• Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
• DOR per RECIST 1.1 as assessed by the investigator
• TTR per RECIST 1.1 as assessed by the investigator
• Overall survival (OS)
• Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE
• Time to deterioration in EORTC QLQ-C30 physical functioning domain score
• Change from baseline in EORTC QLQ-C30 physical functioning domain score
• Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)

Planned enrollment: 111 (estimated).

• 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
• Cleveland Clinic - Oncology Department, Cleveland, Ohio
• SCRI Oncology Partners, Nashville, Tennessee
• The University of Texas MD Anderson Cancer Center - Texas Medical Center, Houston, Texas

28 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06760819

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 1, 2026. Public record; not medical advice.