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)

Launched by BAYER · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BAY2927088, which is designed for people with advanced solid tumors that have specific changes in a gene known as HER2. These tumors can be located in various parts of the body, such as the colon, rectum, uterus, bladder, and biliary tract, but the trial is not open to those with advanced non-small cell lung cancer. The goal of the study is to find out how well BAY2927088 works and how safe it is for patients. Participants will take the medication in the form of tablets, and the treatment will be given in cycles that last three weeks.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of a solid tumor with a HER2 mutation. They should have already received standard treatments or have no other satisfactory options available. Throughout the trial, doctors will monitor participants closely using scans, heart tests, and regular health check-ups to see how the treatment is affecting them and to ensure their safety. This trial is currently recruiting participants, and it offers an opportunity for those with specific solid tumors to receive a potentially promising treatment.

Gender

ALL

Eligibility 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; 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