Study of Oral Zongertinib Alone or With Other Drugs to Treat Adults With Advanced HER2 Breast, Gastric, Esophageal, or Colorectal Cancer

What this Trial Is About

Researchers are evaluating the best dose of zongertinib, a drug that inhibits HER2, for adults aged 18 years and older with various types of HER2-positive cancers that have spread and cannot be removed by surgery. This study focuses on people whose tumors show HER2 abnormalities and who have not had success with previous treatments. The main goal is to find a dose of zongertinib that patients can tolerate well when combined with other treatments, and to see if zongertinib alone or with these combinations can shrink tumors. Participants receive zongertinib alone or together with other drugs such as trastuzumab deruxtecan, trastuzumab emtansine, trastuzumab with capecitabine, zanidatamab, or mFOLFOX6 with or without trastuzumab. The study has two parts Part 1 involves increasing doses of zongertinib in different groups to find the best tolerated dose. Part 2 randomly assigns participants to different dose groups of zongertinib. Treatment is given in cycles during the study. Throughout the study, participants visit the study site regularly. Doctors monitor tumor size with imaging scans like CT or MRI and check participants health for any side effects. The main measures include identifying dose-limiting toxicities within 21 days and the tumors response over up to 50 months. Safety, drug levels in the body, disease control, progression-free survival, and patient-reported outcomes are also tracked. The study runs until January 2029.

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread