Background:
This study is testing a new experimental immunotherapy drug called M0324. This is the first time it is being given to people (a “first-in-human” study). Researchers want to learn how safe it is, how well patients tolerate it, and how the body processes the drug.
M0324 is designed to help the immune system recognize and attack cancer cells more effectively. It targets a specific protein that is often found in large amounts on some cancer cells and helps activate the immune system so it can better recognize and destroy the tumour.
The Trial:
The main goal of this study is to find a safe and appropriate dose of the new drug M0324 to use in future studies. Researchers will also look for early signs that it may help control cancer and study how the body processes and responds to the drug.
The study has three parts, each testing M0324 in a different way. Every patient will take part in only one of these parts:
- Part 1: M0324 will be given by itself to see how patients tolerate it and to find a safe dose.
- Part 2: M0324 will be given together with pembrolizumab, an approved immunotherapy that helps the immune system attack cancer cells.
- Part 3: M0324 will be given together with a chemotherapy treatment called mFOLFIRINOX, which is already used for certain cancers.
The trial is not “blind”, so both you and your doctor will know which therapy you are receiving.
Basic Eligibility:
- Adults with advanced or metastatic cancer that has spread or come back after standard treatments, or when no standard treatment is available.
Additional eligibility criteria will apply. Please speak to your doctor.
| Hospital / Cancer Centre | Principal Investigator | Location | Trial Status |
|---|---|---|---|
| Hospital / Cancer CentrePrincess Margaret Cancer Centre | Principal InvestigatorNot Given | LocationToronto, ON | Trial StatusNot yet recruiting |
