Condition: Advanced Solid Tumor · Sponsor: EMD Serono Research & Development Institute, Inc.
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).
This description comes directly from the study's public registry record.
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| Yale University School of Medicine | New Haven, Connecticut, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
| NEXT Oncology | San Antonio, Texas, United States | Recruiting |
| Princess Margaret Cancer Centre | Toronto, Canada | Recruiting |
| National Cancer Center Hospital | Chūōku, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07166601