BNT321-02: This study aims to determine the appropriate dose level, safety and effectiveness of chemotherapy with or without another medicine (called BNT321) in people with pancreatic cancer when given after surgeryA 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

Exclusion

• Patients are pregnant or breastfeeding or planning pregnancy or to father children during the trial or within 60 days after last IMP treatment
• A medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol specified assessments or procedures, or that could impact adherence to protocol-described requirements
• Had major surgery within 3 weeks of first dose of the trial treatment, where participation in the trial could compromise the patient's wellbeing in the opinion of the investigator
• Has abnormal electrocardiograms (ECGs) that are clinically significant, such as Fridericia-corrected QT prolongation >470 msec (for women) and >450 msec (for men), (average of three ECGs at least 5 minutes apart)
• Has a history of anaphylactic reaction to human, or humanized, antibody
• Have other known active cancer(s) likely to require treatment in the next 2 years
• Had prior radiotherapy or systemic treatment for PDAC
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic antiinfective therapy that has been administered less than 2 weeks prior to the first dose of BNT321
• Known hypersensitivity to any of the excipients of the experimental product BNT321
• Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell counts <350 cells/μL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections
• Known history/positive serology for Hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy; patients with positive serology must have Hepatitis B virus viral load below the limit of quantification)
• Active Hepatitis C virus infection (patients who have completed curative antiviral treatment with Hepatitis C virus viral load below the limit of quantification are allowed)
• Use of any IMP or device within 21 days before administration of first dose of trial treatment or ongoing participation in the active treatment phase of another interventional clinical trial
• Is subject to exclusion periods from another investigational trial
• Are vulnerable individuals as per ICH E6 definition, i.e., individuals whose willingness to participate in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
• Serum CA19-9 >180 U/mL within 3 weeks of C1D1
• Incomplete macroscopic tumor removal (R2 resection)
• Significant cardiovascular risk (past medical history of coronary stenting or myocardial infarction within 6 months, or New York Heart Association (NYHA) Class III/IV, heart failure, or concurrent unstable angina) or risk factors for QT prolongation (sustained Grade 3 or higher hypokalemia, history of unstable arrhythmia or family history of long QT syndrome)
• Pre-existing neuropathy
• Homozygous UDP glucuronosyltransferase family 1 member A1 (UGT1A1)*28 mutation, if testing required by local regulations
• Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe post-operative uncontrolled diarrhea
• Complete dihydropyrimidine dehydrogenase deficiency, if testing required by local regulations
• Received a live vaccine within 3 weeks prior to the first dose of trial treatment
• Patients with a contraindication to receiving mFOLFIRINOX
• Patients with active or latent tuberculosis or history of Mycobacterium tuberculosis infection currently or within the last 2 years
• Individuals committed to an institution by virtue of an order issued either by the judicial or the administrative authorities