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Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Sponsor: Ruijin Hospital
Summary
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
Official title: A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-09-24
Completion Date
2027-08
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
ABO2102
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Toripalimab
Anti-PD-1 antibody, administered intravenously
Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China