Sponsor: BioNTech Pharmaceuticals
Sponsor Study ID: BNT321-02
Study Title: A Phase I/Randomized Phase II, Open-Label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients with Pancreatic Adenocarcinoma
CTO #: 103966
NCT Number: NCT06069778
Phase: I/II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Pancreas
Study Objectives: To assess the safety and identify the RP2D of BNT321 in combination with mFOLFIRINOX as adjuvant therapy in patients with R0 or R1 resected PDAC. To assess the efficacy of mFOLFIRINOX + BNT321 versus mFOLFIRINOX alone as adjuvant therapy in PDAC patients post R0 or R1 resection by mDFS. To further assess the efficacy of mFOLFIRINOX + BNT321 or mFOLFIRINOX as adjuvant therapy in PDAC patients post R0 or R1 resection by OS.