eligibility_summary
Adults ≥18 with histologic solid tumors, failed/intolerant/refused SOC, measurable with ≥1 injectable lesion 10–60 mm, ECOG 0–1, life ≥12 wks, washouts met (T‑VEC ≥12 wks). Exclude: unresolved ≥G2 tox, recent surgery/investigational therapy, active CNS mets, active autoimmune disease, unsafe injection sites, immunosuppression, infection incl HSV or HIV/HBV/HCV, hepatic decomp/effusions, cardiac disease/abnormal ECG, bleeding risk/AC, hypersensitivity/vaccinia, prior BS006. Part 2: melanoma/CSCC only.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05938296 (Phase 1, suspended). Intervention: BS006 (oHSV2-PD-L1/CD3-BsAb), an intratumorally injected, replication-competent oncolytic herpes simplex virus type 2 engineered to secrete a PD-L1×CD3 bispecific T‑cell engager. Mechanisms of action: (1) Oncolysis—selective infection and replication in tumor cells causing direct cell lysis and release of tumor antigens, (2) In situ immune activation—viral PAMPs trigger innate sensing (e.g., TLRs/cGAS–STING) and type I IFN, inflaming the tumor microenvironment, (3) T‑cell redirection—secreted PD-L1/CD3 BsAb binds PD-L1 on tumor/immune cells and CD3 on T cells to form synapses and activate polyclonal T cells locally, potentially also blocking PD-1/PD-L1 inhibitory signaling. Targets: PD-L1+ tumor and myeloid cells, CD3 on T cells, infected tumor cells for lysis, innate pathways (TLR/cGAS–STING) within the tumor. Indication: advanced/metastatic solid tumors amenable to intratumoral injection.