Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 10:22 PM
Study NCT ID:
NCT06577532
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
Sponsor:
Ruijin Hospital
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: