eligibility_summary
Inclusion: 18–75, unresectable advanced solid tumors, ECOG 0–1, ≥12-wk life expectancy, FFPE tumor available for NGS, adequate organs, contraception during and 180 days after. Exclusion: unresolved ≥G2 AEs, other malignancy <3 yrs, recent investigational therapy, prior adoptive cell therapy/vaccines, recent chemo/RT/immune activators/herbal meds, recent major surgery/trauma, live vaccines recent/planned, active autoimmune on immunosuppression, HIV, HBV DNA ≥500 IU/mL, HCV RNA+, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06497010 tests an individualized neoantigen mRNA cancer vaccine (InnoPCV, mRNA vaccine) plus a PD‑1 inhibitor (tislelizumab or sintilimab, monoclonal antibodies). InnoPCV encodes patient-specific tumor neoantigens, after intramuscular injection, mRNA is taken up by antigen‑presenting cells (especially dendritic cells), translated, and peptides are presented on MHC I/II to prime and expand tumor‑specific CD8+ cytotoxic and CD4+ helper T cells. PD‑1 antibodies block the PD‑1 checkpoint on T cells, preventing PD‑1/PD‑L1 inhibitory signaling and restoring effector function in the tumor microenvironment. Targets/pathways: dendritic cells and antigen presentation (MHC I/II), TCR‑mediated T‑cell activation, PD‑1/PD‑L1 immune checkpoint, and downstream cytotoxic T‑cell killing of tumor cells. Design: PD‑1 run‑in, combo with InnoPCV, then PD‑1 maintenance in advanced solid tumors.