{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T16:32:05Z","timestamp":1792513925045,"version":"4.5.0"},"reference-count":41,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"32","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2025,11,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of BL-B01D1, a potential first-in-class epidermal growth factor receptor (EGFR)\u2013human EGFR 3 bispecific antibody-drug conjugated (ADC) with Ed-04, in patients with locally advanced or metastatic urothelial carcinoma (la\/mUC) refractory to standard or regular therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>BL-B01D1-201 is a multicenter, single-arm, phase II study of BL-B01D1 in patients with la\/mUC who have progressed on systemic therapy. Patients received BL-B01D1 at a dose of 2.2, 2.5, or 2.75 mg\/kg intravenously over approximately 60 minutes on days 1 and 8 once every 3 weeks. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>A total of 41 patients were enrolled, 34 in 2.2 mg\/kg, four in 2.5 mg\/kg, and three in the 2.75 mg\/kg group. In the 2.2 mg\/kg group, the confirmed ORR was 44.1% (95% CI, 27.2 to 62.1) and the DCR was 88.2% (95% CI, 72.5 to 96.7). Among 15 patients who had received only one previous line of chemotherapy (either platinum-based or ADCs), the confirmed ORR achieved 80% (95% CI, 51.9 to 95.7). With a median follow-up of 10.2 months, the median PFS was 7.3 months (95% CI, 5.5 to 9.8) and the median DOR was 11.3 months (95% CI, 4.3 to not reached). The most common treatment-related adverse events (all grade\/\u2265grade 3) were anemia (88.2%\/38.2%), leukopenia (76.5%\/38.2%), neutropenia (64.7%\/41.2%), thrombocytopenia (64.7%\/32.4%), appetite decrease (52.9%\/2.9%), and nausea (52.9%\/2.9%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>BL-B01D1 showed promising preliminary efficacy and a favorable safety profile at 2.2 mg\/kg in patients with la\/mUC who had progressed after systemic therapy. These results suggest that BL-B01D1 could be a promising new agent for patients with la\/mUC with few treatment options.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-00109","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T19:59:28Z","timestamp":1759953568000},"page":"3505-3515","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and Safety of BL-B01D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: A Phase II Clinical Trial"],"prefix":"10.1200","volume":"43","author":[{"given":"Xiaojie","family":"Bian","sequence":"first","affiliation":[{"name":"Department of Urology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China"},{"name":"Department of Oncology, Fudan University Shanghai Medical College, Shanghai, 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