eligibility_summary
Inclusion: Adults ≥18 with advanced/recurrent/metastatic solid tumors lacking standard options, HLA genes without CNV/LOH, tumor tissue for WES/RNAseq with ≥1 self‑HLA–presented antigen, measurable disease (RECIST 1.1), ECOG 0–1, life ≥4 mo, adequate organs, contraception, no active CMV/EBV, HIV, HBV, HCV, syphilis. Exclusion: recent therapy/surgery, transplants, prior vaccines/cell therapy, uncontrolled CNS mets or other active cancer, ILD, major CV disease, severe allergy/immunodeficiency, serious infection, other trials, systemic steroids, pregnancy, bleeding risk, active pneumonia/effusions, unresolved ≥G2 AEs, active HBV/HCV viremia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: mRNA-0217/S001 personalized neoantigen tumor vaccine (biological, mRNA vaccine) alone in dose escalation, then combined with pembrolizumab (immune checkpoint inhibitor, anti–PD-1 humanized monoclonal antibody) in expansion. Mechanisms: The mRNA vaccine encodes patient-specific tumor neoantigens (identified by WES/RNAseq), which are translated in host antigen-presenting cells and presented via HLA to prime/expand neoantigen-specific CD8+ cytotoxic and CD4+ helper T cells. Pembrolizumab blocks PD‑1 on T cells, preventing PD‑1/PD‑L1 inhibitory signaling to sustain and reinvigorate antitumor T-cell function. Targets: tumor mutation–derived neoantigens (e.g., KRAS, TP53) presented by patient HLA, dendritic cell antigen presentation, effector CD8+/CD4+ T cells, PD‑1 immune checkpoint pathway. Population: advanced pancreatic cancer. Goal: enhance neoantigen-specific immunity and clinical responses.