eligibility_summary
Adults ≥18 with measurable, inoperable/metastatic melanoma, TNBC, non‑sq NSCLC, synovial/myxoid RC sarcoma, osteosarcoma, or CRC/sarcoma with NY‑ESO‑1/MAGE‑A3+, needing CPI, biopsy/injection‑feasible lesion, ECOG 0–1, adequate labs, negative pregnancy/contraception, prior CPI allowed (6‑wk washout). Exclude: prior oncolytic/live vax, immunosuppression, recent RT/other trial, active infection (incl HIV/HBV/HCV/TB) or autoimmune disease, therapeutic anticoagulation, active CNS mets (asymptomatic allowed), severe prior PD‑1/PD‑L1 AEs, transplant, pregnancy/breastfeeding, conflicting malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
START (NCT05492682) evaluates PeptiCRAd-1 with pembrolizumab after low-dose cyclophosphamide in injectable solid tumors expressing NY-ESO-1/MAGE-A3. PeptiCRAd-1 is a peptide-coated, conditionally replicating oncolytic adenovirus (viral immunotherapy) given intratumorally (± subcutaneously). Mechanism: selective tumor infection/replication causes oncolysis and danger signals, the NY-ESO-1/MAGE-A3 peptide coat boosts dendritic cell uptake and cross-priming of antigen-specific CD8+ T cells (in situ vaccination). Pembrolizumab is an anti–PD-1 monoclonal antibody checkpoint inhibitor restoring T-cell function. Cyclophosphamide (low dose, alkylating agent) provides immune conditioning by reducing regulatory T cells. Targets/pathways: tumor cells, dendritic cells/APCs, NY-ESO-1 and MAGE-A3–specific T cells, and the PD-1/PD-L1 axis.