eligibility_summary
Adults ≥18 with resectable HNSCC, select STS, or TNBC, ECOG 0–2, consent/comply, at least one surface-accessible viable tumor for CIVO, contraception as required. Exclude: unsafe tumor location, pregnancy/lactation, uncontrolled illness or autoimmune, cutaneous-origin HNSCC, HIV or active HBV/HCV, recent (≤3 wks) systemic therapy or immunosuppression (incl ≥20 mg steroids), growth factors, or local RT, live vaccine ≤4 wks, allogeneic transplant, active infection, if study delays surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: PBA-0405—an investigational intratumoral immunotherapy biologic (exact molecular target not disclosed) delivered as subtherapeutic microdoses via the CIVO multi-needle injector. Mechanism of action: Intended to trigger local immune-mediated effector functions within the tumor microenvironment to induce tumor cell killing, study assesses pharmacodynamic biomarker changes after microdose exposure rather than clinical efficacy. Targeted cells/pathways: Local tumor microenvironment—immune effector pathways and cells driving antitumor activity (immune-mediated cytotoxicity within the tumor), specific receptor/antigen targets are not specified. Indications: HNSCC, select soft tissue sarcomas, and TNBC.