eligibility_summary
Adults ≥18 with advanced/metastatic solid tumors after ≥1 prior therapy, measurable disease, ≥1 injectable lesion, biopsy/tissue available, no SOC options, ECOG 0–2, toxicities ≤G1, adequate labs, negative pregnancy/contraception. Expansion: PD‑1‑eligible and progressed on PD‑1. Exclude unsafe lesion site, therapy ≤21d, uncontrolled/steroid‑dependent CNS mets, recent severe infection, immunosuppression/active autoimmune, lung disease/pneumonitis, prior grade‑4 PD‑1 toxicity, concurrent malignancy, active TB/HIV/HBV/HCV, major cardiac disease, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: VAX014, an intratumoral oncolytic biologic made of recombinant bacterial minicells (nonreplicating, noninfectious), tested alone and combined with nivolumab or pembrolizumab (PD‑1–blocking monoclonal antibodies). Mechanisms: VAX014 is designed to kill tumor cells via targeted oncolysis after direct injection, potentially increasing local tumor antigen release and inflammation. Nivolumab/pembrolizumab inhibit the PD‑1 checkpoint to restore antitumor T‑cell activity. Targets: tumor cells in injected lesions (direct lysis) and the PD‑1 pathway on T cells (reversing immune suppression in the tumor microenvironment).