{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["disitamab vedotin"]],"indication":"HER2-overexpressing locally advanced or metastatic urothelial carcinoma","name":"RC48-C009","nct_id":"NCT03809013","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rc48-c009-nct03809013. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will be treated with RC48-ADC 2.0 mg/kg, once every 2 weeks (Q2W) until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).","label":"RC48-ADC","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-06-05","type":"ACTUAL"},"conditions":["Urothelial Carcinoma"],"enrollment":{"count":64,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"RC48-ADC","otherNames":["Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection"],"type":"DRUG"}],"last_update":"2023-11-27","lead_sponsor":"RemeGen Co., Ltd.","official_title":"A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-03-04","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate （ORR）as assessed by the Independent Review Committee","timeFrame":"24 months"}],"references":[{"citation":"Sheng X, Wang L, He Z, Shi Y, Luo H, Han W, Yao X, Shi B, Liu J, Hu C, Liu Z, Guo H, Yu G, Ji Z, Ying J, Ling Y, Yu S, Hu Y, Guo J, Fang J, Zhou A, Guo J. Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials. J Clin Oncol. 2024 Apr 20;42(12):1391-1402. doi: 10.1200/JCO.22.02912. Epub 2023 Nov 21.","pmid":"37988648","type":"DERIVED"}],"start_date":{"date":"2019-01-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT03809013"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rc48-c009-nct03809013"}