eligibility_summary
Eligibility: Adults ≥18 with advanced solid tumors harboring target KRAS mutation, progressed/intolerant after ≥1 systemic therapy (or, in stage 2, untreated but likely to benefit), ECOG 0–2, life expectancy ≥12 weeks, adequate organ function. Exclude: other active malignancy ≤5y, prior KRAS vaccine, recent immunosuppression/immunodeficiency/transplant, severe allergy, uncontrolled infection/TB, severe CV disease, untreated symptomatic CNS mets, active autoimmune/inflammatory disease, uncontrolled eczema/asthma, other serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: ABO2102, an intramuscular mRNA nanoparticle vaccine encoding mutant KRAS neoantigens, and toripalimab, an IV anti–PD-1 monoclonal antibody (IgG4). Mechanisms: ABO2102 is taken up by dendritic/antigen-presenting cells, translated and presented on MHC I/II to prime and expand KRAS-specific CD8+ cytotoxic and CD4+ helper T cells for tumor cell killing. Toripalimab blocks PD-1 on T cells to reverse exhaustion and boost vaccine-elicited T-cell function. Targets/pathways: KRAS neoantigen–expressing tumor cells, APC/T-cell priming, MHC I/II antigen presentation, TCR recognition, PD-1/PD-L1 checkpoint axis. Design: Early Phase 1 dose escalation/expansion, monotherapy and combination in KRAS-mutated pancreatic and other solid tumors.