This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adebrelimab is a programmed death-ligand 1 antibody.
neoantigen personalized mRNA vaccines
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China
DLT
Percentage of subjects who meet the criteria of DLT in DLT observation period
Time frame: Day 1 to Day 28 after the first tumour vaccine was administrated
MTD/MAD
Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)
Time frame: From first dose up to end of the study, assessed up to 36 months
RDE
Recommended dose of expansion
Time frame: From first dose up to end of the study, assessed up to 36 months
AE
Percentage of subjects with Adverse Events (AEs)
Time frame: From date of ICF up to end of the study, assessed up to 36 months
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