An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma
Sponsor study identifier
interventional
60
1 country
1
Study Start
July 22, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 23, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2025
Actual (reported)April 6, 2025
Actual (reported)July 22, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 23, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
DLT
Percentage of subjects who meet the criteria of DLT in DLT observation period
Day 1 to Day 21 after the first tumour vaccine was administrated
AE
Percentage of subjects with Adverse Events (AEs)
From ICF up to 30days after last study treatment
RFS
2 years
OS
2 years
Resectable PDAC
AK154 is neotigeon personalized mRNA vaccine
a PD-1/CTLA-4 bispecific antibody
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
Shanghai, Xuhui, 200032, China
First Submitted
March 30, 2025
First Posted
April 6, 2025
Study Start
July 22, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 23, 2028
EstimatedOncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC
a PD-1/VEGF bi-specific antibody
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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