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Treatment for solid tumors with HER2 mutations using BAY2927088 tablets

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

PHASE2 · Bayer · NCT06760819

This study is testing if BAY2927088 tablets can help people with advanced solid tumors that have HER2 gene mutations feel better and manage their cancer.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment111 (estimated)
Ages18 Years and up
SexAll
SponsorBayer (industry)
Drugs / interventionssevabertinib
Locations54 sites (Birmingham, Alabama and 53 other locations)
Trial IDNCT06760819 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of BAY2927088 tablets in patients with advanced solid tumors that have mutations in the HER2 gene. The study focuses on various types of cancers, including colorectal, biliary tract, bladder, and cervical cancers, while excluding non-small cell lung cancer. Participants must have a documented HER2 mutation and measurable lesions to qualify for the trial. The goal is to understand how well this treatment can block the abnormal HER2 protein associated with tumor growth.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that have documented HER2 mutations.

Not a fit: Patients with primary non-small cell lung cancer or those who have previously received HER2 tyrosine kinase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors harboring HER2 mutations.

How similar studies have performed: Other studies targeting HER2 mutations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumors, HER2 Mutation, Colorectal cancer, CRC, Biliary tract cancer, BTC, Bladder cancer, Cervical cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.