{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":[["EG-70"]],"indication":"high-risk non-muscle invasive bladder cancer","name":"NCT04752722","nct_id":"NCT04752722","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04752722. 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":"Dose escalation phase","label":"Phase 1","type":"EXPERIMENTAL"},{"description":"Cohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment.\n\nCohorts 2A, 2B and 3: RP2D with eligible high-risk NMIBC patients with CIS who are BCG-naïve, BCG-exposed (incompletely treated with BCG) or BCG-unresponsive HG Ta/T1 papillary disease without CIS","label":"Phase 2","type":"EXPERIMENTAL"},{"description":"BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment.\n\nBladder Rinse Cohort: a 5-minute bladder rinse prior to administration of RP2D of detalimogene voraplasmid (EG-70) with a shortened administration time of 30 minutes.","label":"Phase 1 Substudy Surfactant Bladder Rinse","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-10-30","type":"ESTIMATED"},"conditions":["Superficial Bladder Cancer","Non-muscle Invasive Bladder Cancer With Carcinoma in Situ","Non-muscle Invasive Bladder Cancer"],"enrollment":{"count":350,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"EG-70 (phase 1)","otherNames":["Phase 1"],"type":"DRUG"},{"name":"EG-70 (phase 2) Master Protocol","otherNames":["Phase 2"],"type":"DRUG"},{"name":"Surfactant Bladder Pre-Rinse and EG-70 (Substudy)","otherNames":["Phase 1 Bladder Rinse","Surfactant"],"type":"DRUG"}],"last_update":"2026-08-07","lead_sponsor":"enGene, Inc.","official_title":"A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-04-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.","timeFrame":"Approximately 2 years"},{"measure":"Phase 2: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies.","timeFrame":"Approximately 24 weeks"},{"measure":"Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0)","timeFrame":"Approximately 3 years"}],"references":[],"start_date":{"date":"2021-04-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve","url":"https://clinicaltrials.gov/study/NCT04752722"},"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/nct04752722"}