Phase 1 First-In-Human Study to Explore the Safety Tolerability and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Brief description of study

This study is investigating a drug called AMG 305, which is designed to target specific cancer cells that have CDH3 and MSLN. This is a unique drug that brings T cells to tumors that express CDH3 and MSLN (commonly seen in non-small cell lung cancer, pancreatic cancer and colorectal cancer). The study wants to find out if AMG 305 is safe and effective for treating advanced or metastatic solid tumors. The study will be done in different stages. In the first stage, called "Dose Exploration," a small group of participants will receive different doses of the drug to see what dose works best in treating the tumors. The dose will be slowly increased until they find the highest dose that is safe. The participants will be closely watched to see how they respond to the treatment. Once they know the safe and effective dose, they will move on to the second stage, called "Dose Expansion." In this stage, more participants with different types of tumors will join the study. They will receive different doses and schedules of the drug to confirm its safety and effectiveness. They will also do extra tests to learn more about how the drug works. During the study, participants will get AMG 305 through short-term IV infusions. The dose may change based on how they react to it. Participants who benefit from the treatment may have the option to get it again later. But if they had to stop because of bad side effects, they won't be able to get it again. [The study has a careful plan and will use the information from each stage to make sure AMG 305 is safe and effective for treating solid tumors.




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