Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

December 9, 2024

Study Completion Date

June 16, 2025

Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

NP137

NP137 will be administrated at the first day of each cycle (CnD1) of 14 days as an IV infusion at 9 or 14 mg/kg.

DRUG

Oxaliplatin

Oxaliplatin will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 85 mg/m²

DRUG

Irinotecan

Irinotecan will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 150 mg/m²

DRUG

Calcium levofolinate

Calcium levofolinate will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 100 mg/m²

DRUG

5 FU

5 FU will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 2400 mg/m2 as a continuous intravenous infusion over 46 hours.

Trial Locations (9)

33404

CHU de BORDEAUX, Bordeaux

35033

CHU Rennes, Rennes

38043

CHU de GRENOBLE ALPES, Grenoble

42055

CHU St Etienne, Saint-Etienne

51092

CHU de REIMS, Reims

59037

CHRU Lille, Lille

69008

Hôpital Privé Jean Mermoz, Lyon

75013

AP-HP Pitié Salpetrière, Paris

86000

CHU Poitiers, Poitiers

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NETRIS Pharma

INDUSTRY

lead

University Hospital, Grenoble

OTHER

NCT05546853 - Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma | Biotech Hunter | Biotech Hunter