NCT06913218

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino

Conditions

• Pancreas Cancer
• Pancreas Cancer, Duct Cell Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-02-23
• Completion: 2028-11-06
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: China