eligibility_summary
Adults 18–75 with unresectable locally advanced/metastatic urothelial carcinoma, no prior systemic therapy, ECOG 0–1, life expectancy ≥3 mo, measurable lesion, recent tumor tissue, adequate organ function, resolved prior toxicities, contraception/pregnancy rules. Exclude prior TOPI-ADC, recent RT/immunomodulators, severe irAEs, active autoimmune/ILD/infection, CNS mets, major CV/arrhythmia, uncontrolled DM/HTN, prior transplants, significant effusions/bleeding, live vaccines, other high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06405425 (Phase II) in locally advanced/metastatic urothelial carcinoma. Interventions: - BL-B01D1 (izalontamab brengitecan, BMS-986507): a bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3 (ERBB3). After antigen binding and internalization, it delivers a camptothecin-class topoisomerase I inhibitor payload (brengitecan) to induce DNA damage and tumor cell death (with potential bystander effect). - PD-1 inhibitor (anti–PD-1 monoclonal antibody, immune checkpoint inhibitor): blocks PD-1 on T cells to restore antitumor immunity. Targeted cells/pathways: - Tumor cells overexpressing EGFR/HER3, inhibition of EGFR/HER3 signaling and topo I–mediated DNA replication/repair leads to cytotoxicity. - T cells within the tumor microenvironment via PD-1/PD-L1 pathway, enhancing T‑cell activation and cytotoxic response against urothelial cancer cells. Combination aims to couple direct ADC-mediated killing with immune reactivation.