eligibility_summary
Adults ≥18 with advanced/metastatic urothelial (transitional cell) cancer, ≤2 prior lines (adjuvant/neoadjuvant allowed), life expectancy ≥12 wks, consent, able to comply. COVID vaccine not required (if vaccinated: primary series completed, ≥14 days). Exclude: active infection, other active cancer, untreated/unstable brain mets, major autoimmune (exceptions), immunodeficiency/transplant, recent immunosuppressants/steroids/live vaccines, uncontrolled HIV, pregnancy/breastfeeding/no contraception, recent trial/surgery/trauma, prior NAP/pembro/Obi, serious CV disease, drug allergy, PML.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 (withdrawn) single-arm study in urothelial cancer testing: 1) Naptumomab estafenatox (NAP), a tumor‑targeted superantigen fusion protein (TTS, anti‑5T4 Fab linked to a bacterial superantigen) designed to bind 5T4 on tumor cells and polyclonally activate T cells via TCR Vβ engagement at the tumor site, 2) Pembrolizumab, an anti‑PD‑1 monoclonal antibody immune checkpoint inhibitor restoring exhausted T‑cell activity, 3) Obinutuzumab, a type II anti‑CD20 glycoengineered monoclonal antibody used pre‑treatment to deplete B cells and reduce anti‑drug antibodies/modify the immune milieu. Targets/pathways: 5T4+ urothelial tumor cells, TCR Vβ–mediated T‑cell activation, PD‑1/PD‑L1 checkpoint axis on T cells/tumor/immune cells, CD20+ B‑cell compartment. The strategy aims to amplify tumor‑localized T‑cell cytotoxicity and sustain it by PD‑1 blockade.