Phase II Study of Tucatinib and Ado-trastuzumab Emtansine T-DM1 for HER2-positive Metastatic Solid Tumors with Brain Metastases

What this Trial Is About

Researchers are evaluating the combination of tucatinib and ado-trastuzumab emtansine T-DM1 in patients with HER2-positive metastatic solid tumors that have spread to the brain. This Phase II study aims to determine how well this drug combination controls brain metastases, assessing tumor response using specific criteria and measuring safety and tolerability. The study also explores the effects on cancer cell activity and biomarkers. Participants will take tucatinib tablets twice daily, about 8 to 12 hours apart, and receive T-DM1 by intravenous infusion over about 30 minutes on the first day of each 21-day cycle. Treatment cycles repeat every three weeks. The study includes ongoing monitoring of tumor response in the brain and body, as well as evaluation of side effects and overall patient survival. During the study, participants will undergo brain MRI scans, echocardiograms or MUGA scans, blood tests, and other laboratory assessments to monitor tumor activity, safety, and organ function. Researchers will track adverse events and measure progression-free and overall survival. The study lasts until disease progression or other criteria are met, with an average safety follow-up of about one year.

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)