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Taking people in CanadaPhase 2

Tests sevabertinib in solid tumors with HER2 gene mutations

Tests sevabertinib tablets in adults with solid tumors carrying HER2 mutations.

Key facts

Who runs it
Bayer
Where
Halifax, Montreal, and Toronto, CanadaSee the 3 sitesAlso in 10 other countries, 51 sites
Registry 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)
Status
Recruiting
Phase
Phase 2
People taking part
111 people, planned
Started
13 Feb 2025
Expected to end
26 Oct 2029
Type of study
Interventional
Treatments tested
  • BAY2927088
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors (not lung cancer) that have a HER2-activating mutation. Everyone takes sevabertinib (BAY 2927088) tablets.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Solid tumor that is locally advanced, cannot be removed by surgery, or has spread. Types listed: colorectal, biliary tract, bladder and urothelial tract, cervical, endometrial, breast, or another solid tumor, but not non-small cell lung cancer (NSCLC). At least one lesion that can be measured on scans (RECIST 1.1).
Earlier treatment
Must have had the standard treatment for their tumor type and stage, or have no satisfactory other treatment. Cannot have had a HER2 tyrosine kinase inhibitor (TKI) before.
Biomarker or test result
A documented activating HER2 mutation.

Main reasons for not taking part

  • Main diagnosis of non-small cell lung cancer (NSCLC)
  • Earlier treatment with a HER2 tyrosine kinase inhibitor (TKI)
  • Active brain metastases
  • Uncontrolled, severe illness at the same time

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
  • Primary diagnosis of non-small cell lung cancer (NSCLC)
  • Uncontrolled, severe, intercurrent illness
  • Active brain metastases

Where in Canada

Also in 10 other countries, 51 sites

  • Queen Elizabeth II Health Sciences Centre | OncologyHalifax, CanadaNo longer taking part
  • Research Institute of the McGill University Health Centre | Women Health's Research UnitMontreal, CanadaNo longer taking part
  • Princess Margaret Cancer Centre | Medical Oncology and HematologyToronto, CanadaTaking people

About the trial

What the trial wants to find out

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

Read full original descriptionShow less

In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).

Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.

The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.

The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.

During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

The group in the trial

  • BAY2927088Treatment being tested

    Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests sevabertinib in solid tumors with HER2 gene mutationsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026