{"entity":{"id":"nct07424287","kind":"trial","name":"A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC","aka":["NiBladder 1"],"tldr":"A phase 3 trial testing SHR-1501 in bladder & urothelial cancer, now recruiting.","summary":"A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC is a phase 3 interventional study registered as NCT07424287, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1). Planned enrolment is 236 participants (estimated). The study started in 2026-07-13 and primary completion is expected in 2030-06. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07424287","url":"https://clinicaltrials.gov/study/NCT07424287"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["shr-1501","pirarubicin"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07424287","phase":"3","setting":"A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)","sponsor":"Suzhou Suncadia Biopharmaceuticals","started":"2026-07-13","startedType":"actual","enrolled":236,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07424287/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"drug":[{"id":"pirarubicin","kind":"drug","name":"Pirarubicin","route":"/drugs/pirarubicin/"},{"id":"shr-1501","kind":"drug","name":"SHR-1501","route":"/drugs/shr-1501/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}]}}