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Zunsemetinib · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Dose escalation phase (zunsemetinib + mFOLFIRNOX) | EXPERIMENTAL | The dose of zunsemetinib will be determined by the dose level assigned and will be taken by mouth either once or twice daily depending on assigned dose level. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length. |
| Dose expansion phase (zunsemetinib + mFOLFIRNOX) | EXPERIMENTAL | The dose of zunsemetinib will be determined during the dose escalation phase of the trial. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length. |
| Name | Type | Description |
|---|---|---|
| Zunsemetinib | DRUG | Patients should take zunsemetinib approximately 12 hours apart (if twice daily dosing) or 24 hours apart (if once daily dosing) at the same time(s) every day, with 8 oz of water. |
| mFOLFIRINOX | DRUG | Includes oxaliplatin, irinotecan, leucovorin, and 5-FU. |
Inclusion Criteria: * Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease. Patients with mixed cytology in their tumors such as adeno-squamous, mixed neuroendocrine-carcinoma are permitted if the portion of a...
Zunsemetinib is an investigational small molecule being studied for the treatment of metastatic pancreatic ductal adenocarcinoma, a form of pancreatic cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Zunsemetinib is a kinase inhibitor, as indicated by its -tinib suffix. It is being studied in combination with the chemotherapy regimen mFOLFIRINOX for patients with untreated metastatic pancreatic ductal adenocarcinoma.
Zunsemetinib is being developed by Aclaris Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACRS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Zunsemetinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing trial is recruiting participants to assess the drug in combination with mFOLFIRINOX.
Zunsemetinib is being evaluated in a Phase 1 clinical trial with the identifier NCT06648434. This trial is recruiting 51 participants in the United States and is studying the drug in combination with mFOLFIRINOX for untreated metastatic pancreatic ductal adenocarcinoma.