eligibility_summary
Inclusion: Adults ≥18, ECOG 0–2, MIBC cT2–T4/cN0–1 with urothelial or squamous histology, TURBT-confirmed ≤90 days, ineligible or unwilling for cystectomy and/or cisplatin (incl. Galsky cisplatin-unfit). Adequate organs, CrCl ≥30. Controlled HIV on stable ART allowed. Exclude pregnancy, hypersensitivity, prohibited meds, prior chemo/targeted/topo‑I, recent biologic, active 2nd cancer (limited exceptions), neuroendocrine, active IBD/GI perf, serious infection, active HBV/HCV, uncontrolled HIV, recent investigational drug.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm bladder-preservation strategy in cisplatin-unfit or cystectomy-unwilling MIBC. Interventions and mechanisms: 1) Sacituzumab govitecan (Trodelvy): an antibody–drug conjugate (ADC) targeting Trop‑2 on tumor cells. Upon binding and internalization, it releases SN‑38 (active metabolite of irinotecan), a cytotoxic topoisomerase I inhibitor that causes DNA damage and apoptosis, ADC type: humanized anti–Trop‑2 IgG linked to SN‑38. 2) Zimberelimab (AB122/GLS‑010): an immune checkpoint inhibitor, anti–PD‑1 IgG4 monoclonal antibody that blocks PD‑1 on T cells, restoring antitumor T‑cell activity. Target cells/pathways: Trop‑2–expressing urothelial carcinoma cells, DNA replication/Topoisomerase I pathway, PD‑1/PD‑L1 immune checkpoint on activated T lymphocytes in the tumor microenvironment. Primary endpoint: event-free survival.