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NOT YET RECRUITING
NCT06913218
PHASE1

A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-07-22

Completion Date

2028-11-06

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

AK154

AK154 is neotigeon personalized mRNA vaccine

BIOLOGICAL

Cadonilimab

a PD-1/CTLA-4 bispecific antibody

BIOLOGICAL

Ivonescimab (SMT112 or AK112) Injection

a PD-1/VEGF bi-specific antibody

DRUG

mFOLFORINOX

mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

Locations (1)

Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center

Shanghai, Xuhui, China