{"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":null,"indication":null,"name":"NCT05316155","nct_id":"NCT05316155","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05316155. 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 with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D\\[s\\]) for Part 2.","label":"Part 1: Dose Escalation","type":"EXPERIMENTAL"},{"description":"Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.","label":"Part 2: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.","label":"Part 3: RP2D Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D.","label":"Part 4: Phase 2 Expansion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2029-07-24","type":"ESTIMATED"},"conditions":["Non-Muscle Invasive Bladder Neoplasms"],"enrollment":{"count":235,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Erdafitinib Intravesical Delivery System","otherNames":["JNJ-42756493"],"type":"DRUG"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-03-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Parts 1 to 3: Number of Participants with Adverse Events (AEs)","timeFrame":"Up to approximately 7 years 4 months"},{"measure":"Parts 1 to 3: Number of Participants with AEs by Severity","timeFrame":"Up to approximately 7 years 4 months"},{"measure":"Part 1: Number of Participants with Dose-limiting Toxicity (DLT)","timeFrame":"Up to 28 days"},{"measure":"Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)","timeFrame":"Up to approximately 7 years 4 months"}],"references":[],"start_date":{"date":"2022-04-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT05316155"},"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/nct05316155"}