Study Purpose: This study tests a new drug, DB-1303/BNT323, to see if it is safe and tolerated by people with advanced solid tumors. Tumors are abnormal growths of cells. The tumors in this study are advanced, meaning they are hard to remove or have spread to other parts of the body. Researchers are especially interested in tumors that have a protein called HER2. HER2 is a protein that can help cancer cells grow.
Study Design: The study has two parts. Part 1 finds out the best dose of the drug. Part 2 checks if the best dose is safe and how well it works. Participants will receive multiple doses of the drug, and their health will be monitored closely. The study is open-label, so both doctors and participants know what treatment is given.
- Participants must have a HER2-positive tumor and be unable to use standard treatments.
- The study is held at multiple centers, but participants may need to travel for visits.
- Participants may experience side effects, as this is a first-in-human (FIH) study.
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