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A Study of Sevabertinib (BAY 2927088) for HER2-Mutated Solid Tumors

This study is testing a treatment called sevabertinib (BAY 2927088) in people with advanced solid tumors that have specific changes (mutations) in a gene called HER2. Researchers want to see how safe sevabertinib is and how well it works to shrink these tumors. You may be able to join if you are at least 18 years old and have certain types of solid tumors, such as colorectal, breast, bladder, or uterine cancer, with a HER2 mutation. The study aims to enroll 111 participants and will measure how many people experience tumor shrinkage. The current status of this study is unclear.

Study design
This interventional study is testing sevabertinib (BAY 2927088) in about 111 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study intervention until the first documented progression, or death, or end of study, for up to approximately 3 years.

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NCT06760819

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bayer
~111 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:BAY2927088

At a glance

Recruiting sites
52 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Measured over 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

Conditions

Advanced Solid Tumors
HER2 Mutation

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Where it's being run

54 sites across 39 states
Italy4
South Korea4
Spain3
Switzerland3
Michigan2
New South Wales2
Beijing Municipality2
Shanghai Municipality2

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

    ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \<10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)