Upon joining the study, you will be asked to sign an informed consent form. This document confirms that you understand the study and agree to participate.

You will undergo a screening process to ensure you meet the study’s eligibility criteria. This includes tests to check your overall health and specific tests to confirm the presence of a high level of a protein called CEACAM5 in your tumor.

Once eligibility is confirmed, you will begin treatment with the study medication, M9140. This medication is administered as a powder mixed into a solution and given through an intravenous infusion, which means it is delivered directly into your bloodstream through a vein.

The treatment is given once every three weeks, a schedule referred to as q3w.

Throughout the study, you will continue to receive the M9140 treatment every three weeks. Regular visits to the study site will be necessary for these infusions.

During these visits, your health will be closely monitored. This includes regular blood tests and imaging tests to assess how your cancer is responding to the treatment.

The main goal of the study is to evaluate the objective response to the treatment, which means measuring how much the cancer shrinks or disappears after treatment.

Secondary assessments include monitoring for any side effects, the duration of response, and overall disease control.

Your participation in the study will continue until the study ends or until it is determined that the treatment is no longer beneficial for you.

Upon completion, you will have a final visit where your overall health and response to the treatment will be evaluated.