A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
NCT06913218 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-04-06
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
Conditions
- Pancreas Cancer
- Pancreas Cancer, Duct Cell Adenocarcinoma
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
Sponsors & Collaborators
-
Fudan University
collaborator OTHER - lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-22
- Primary Completion
- 2028-02-23
- Completion
- 2028-11-06
Countries
- China
Study Locations
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