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M0324 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: M0324 Monotherapy | EXPERIMENTAL | - |
| Part 2: M0324 + Pembrolizumab | EXPERIMENTAL | - |
| Part 3: M0324 + mFOLFIRINOX | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M0324 | BIOLOGICAL | M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE). |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab will be administered intravenously as per standard of care. |
| mFOLFIRINOX | DRUG | mFOLFIRINOX will be administered intravenously as per standard of care. |
Inclusion Criteria: Part 1- M0324 Monotherapy: • Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator Part 2- M0324 Combination...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M0324 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development as a monotherapy and in combination with other agents for participants with selected advanced solid tumors.
M0324 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being evaluated in a Phase 1 trial for advanced solid tumors, where it is tested alone and in combination with pembrolizumab or chemotherapy.
M0324 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of M0324 in participants with advanced solid tumors.
M0324 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is recruiting participants with advanced solid tumors.
M0324 is being studied in a single Phase 1 clinical trial with the identifier NCT07166601. The trial is recruiting 77 participants with advanced solid tumors across the United States, Canada, and Japan, and is evaluating M0324 as monotherapy and in combination with pembrolizumab or chemotherapy.
Yes, M0324 is being studied both as a monotherapy and in combination with pembrolizumab or chemotherapy in a Phase 1 trial for advanced solid tumors. The trial is currently recruiting participants and is not randomized or double-blinded.