drugset / Trial / NCT05546853
Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
NaSingle-groupOpen-labelTreatment
Summary
The study will assess the safety of the association of NP137 with the standard of care mFOLFIRINOX in the treatment of locally advanced pancreatic ductal adenocarcinoma.The study drug which is tested is the NP137 in association with mFOLFIRINOX to allow a better tumor response as well as better survival outcomes with an acceptable safety.
Timeline
- Start
- 2023-03-28
- Primary completion
- 2024-12-09
- Completion
- 2025-06-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NP137 | Monoclonal antibody | 9 mg/kg | Intravenous |
| Subject | NP137 | Monoclonal antibody | 14 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | 100 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |