Recruiting

Testing a new pill for solid tumors with HER2 gene mutations

Plain-English translation of NCT06760819 on ClinicalTrials.gov ↗ ·

What is this trial?

This study is testing a new medication called sevabertinib (BAY 2927088) as a tablet treatment for people with advanced solid tumors that have HER2 gene mutations. These mutations cause cancer cells to grow abnormally, and this medication is designed to block the faulty HER2 protein and slow or stop cancer growth. The trial will enroll about 111 adults to see how well and how safely this treatment works.

Some solid tumors develop mutations in the HER2 gene that make cancer cells grow faster and spread more easily. Currently, there are limited treatment options specifically designed for HER2-mutated tumors in many cancer types, so researchers are testing this new medication to see if it can offer better outcomes for patients.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have been diagnosed with an advanced or inoperable solid tumor (such as colorectal, bladder, biliary tract, cervical, endometrial, or breast cancer) that has a HER2-activating mutation
your cancer has at least one measurable tumor that can be tracked on scans
you have already received standard treatments for your cancer type, or no other satisfactory treatment options are available to you
your HER2 mutation has been confirmed through genetic testing

You likely don't qualify if…

you have non-small cell lung cancer
you have previously taken a HER2-targeted tyrosine kinase inhibitor drug
you have active brain metastases (cancer that has spread to your brain)
you have uncontrolled or severe other medical illnesses that would make it unsafe to participate

What participation looks like

You would take the medication as a tablet by mouth twice daily in repeating 3-week cycles for as long as the treatment is working and you are tolerating it well. During the trial, you will have regular visits for imaging scans to monitor your tumor, heart function tests (echocardiogram, cardiac MRI, and ECG), blood and urine tests, physical exams, and conversations with your doctor about how you are feeling and any side effects. The trial will continue until your cancer worsens, you experience unacceptable side effects, or you decide to withdraw.

Testing a new pill for solid tumors with HER2 gene mutations

What is this trial?

Do you qualify?

What participation looks like

Trial locations(54 sites)