eligibility_summary
Adults ≥18 with measurable solid tumors planned for 1st/2nd-line PD-1/PD-L1 therapy, biopsy-accessible disease, ECOG ≤2, life expectancy ≥6 mo, adequate marrow, coagulation, hepatic, renal (eGFR ≥30) function, able to undergo CT/MRI. Exclude symptomatic brain mets, major comorbidities/autoimmune/immunodeficiency/transplant, other malignancy <5y (unless cured ≥2y), active infection (HBV/HCV), HIV, bleeding/anesthesia risk, pregnancy/lactation or unwilling contraception, recent live vaccine/other trials, contraindicated meds, unresolved ≥G2 toxicity, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: NECVAX-NEO1 plus standard anti-PD-1/PD-L1 monoclonal antibodies. NECVAX-NEO1 is an oral, bacteria-based personalized DNA vaccine encoding patient-specific neoantigens (selected by the NEC Immune Profiler) to induce tumor-specific immunity. Mechanism: the bacterial vector delivers neoantigen DNA to antigen-presenting cells, promoting MHC I/II presentation and activation/expansion of neoantigen-specific T cells, anti-PD-1/PD-L1 checkpoint inhibitors block PD-1/PD-L1 signaling to prevent T-cell exhaustion and enhance effector function. Targets: dendritic/APC pathways, CD8+ and CD4+ T cells, the PD-1/PD-L1 axis, and tumor cells expressing the neoantigens.