{"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-positive locally advanced or metastatic urothelial carcinoma","name":"RC48-C005","nct_id":"NCT03507166","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rc48-c005-nct03507166. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","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 receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).","label":"RC48-ADC","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-10-29","type":"ACTUAL"},"conditions":["Urothelial Carcinoma","Advanced Cancer"],"enrollment":{"count":43,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"RC48-ADC","otherNames":["Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection"],"type":"DRUG"}],"last_update":"2019-08-21","lead_sponsor":"RemeGen Co., Ltd.","official_title":"A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2018-10-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate （ORR）","timeFrame":"up to 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"},{"citation":"Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.","pmid":"33109737","type":"DERIVED"}],"start_date":{"date":"2017-12-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT03507166"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rc48-c005-nct03507166"}