eligibility_summary
Eligible: adults ≥18 with injectable lesion(s) ≥10 mm, ECOG 0–1, survival ≥3 mo, ≥28 d from last therapy, adequate organ function, LVEF ≥50%, toxicities ≤G1. Diseases: advanced refractory SCCHN, unresectable stage III or stage IV melanoma after ≥2 lines, or advanced soft‑tissue sarcoma after systemic therapy. Exclude: recent trial, unsafe tumor location, serious heart disease, pregnancy/lactation, active TB/HIV/HBV/HCV, autoimmune disease, recent steroids/immunosuppressants, severe allergy to oncolytic virus, major surgery <28 d, need anti‑HSV drugs or oral herpes, substance abuse/psychiatric illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06080984 tests two intratumoral, genetically engineered oncolytic herpes simplex virus (HSV, DNA virus) therapies: SDJ001 (head and neck SCC) and YD06-1 (melanoma, sarcoma). Mechanisms of action: (1) Direct oncolysis—selective replication in tumor cells (exploiting tumor interferon/antiviral pathway defects) leading to lysis and spread, (2) Immune activation—converts “cold” to “hot” tumors, releases tumor antigens, activates dendritic cells, increases cytotoxic T‑cell infiltration, and reverses immunosuppression (targets Tregs/IL‑10/PD‑L1), (3) Transgene delivery/anti‑angiogenesis—viruses are engineered with virulence gene deletions and express a recombinant bispecific antibody to enhance antitumor immunity, OVs can also be armed with genes like GM‑CSF/IL‑12/IL‑15/anti‑PD‑L1 and can disrupt tumor vasculature with neutrophil recruitment. Targeted cells/pathways: tumor cells, interferon/antiviral signaling, dendritic cells, CD8 T cells, Tregs, IL‑10, PD‑L1, tumor endothelium.