eligibility_summary
Inclusion: 18–75, ECOG 0–1, ≥3‑mo survival, advanced UC/other GU/solid tumors after standard failure (UC post‑platinum, prostate post NHT+taxane, ccRCC post TKI), measurable lesion, tissue preferred, adequate organ/EF, prior AEs ≤G1, contraception. Exclusion: prior topo‑I ADC, recent anti‑cancer tx/surgery, major CV disease, severe irAE/immune myocarditis, active autoimmune/ILD, uncontrolled DM/HTN, recent thrombosis, CNS mets, large effusions, study‑drug allergy, transplant, active HIV/TB/HBV/HCV or serious infection, systemic steroids/immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05965856 (Phase II) tests: 1) SI-B003: an immune checkpoint inhibitor (humanized anti-PD-1 monoclonal antibody). Mechanism: blocks PD-1/PD-L1 signaling to reinvigorate exhausted T cells and enhance antitumor immunity. 2) BL-B01D1 (iza-bren, izalontamab brengitecan, BMS-986507): a TROP2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (brengitecan). Mechanism: binds TROP2 on tumor cells, internalizes, and releases the topo I payload to cause DNA damage and cell death. Targets/pathways: PD-1 on T cells and PD-L1 on tumor/immune cells (immune checkpoint pathway), TROP2 on epithelial tumor cells, DNA replication/repair via topo I inhibition. Indication: previously treated locally advanced/metastatic urothelial carcinoma and other solid tumors.