Clinical trialPhase 1Completed
Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 28 March 2023
- Expected end
- 16 June 2025
- Enrollment
- 43 participants
- Sites
- 9
- Primary outcomes
- Percentage Proportion of patients experiencing adverse events
- Sponsor
- Other
- Results posted
- No
- Last update
- 19 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
The study is a multicentric, prospective, single arm phase 1b trial. This study will enroll 43 to 52 patients and consists of 2 parts: Safety Lead-in Phase and Expansion Phase. Initially, 3 to 12 patients will be enrolled into a Safety Lead-in Phase based on a 3 + 3 design, with the possibility of dose de-escalation, to confirm the recommended dose of NP137.The Expansion Phase will start after completion of Safety Lead-in Phase at the confirmed dose and will include 40 patients. Patients will be assigned to the experimental arm (NP137 + mFOLFIRINOX).