[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725796":3,"trial-entities:NCT07725796":291,"trial-summary:NCT07725796":295},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":50,"secondary_outcomes":67,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":15,"eligibility_criteria":87,"std_ages":111,"locations":114,"central_contacts":279,"overall_officials":284,"references":289,"see_also_links":290},"NCT07725796","UGN-501-101","A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC","A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-501 Administered Intravesically in Adult Participants With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)","NOT_YET_RECRUITING","2029-08-02","2026-07","2026-07-24","2026-09-30","UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.","INDUSTRY",false,"This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).","This is a Phase 1, open-label, dose-escalation, multicenter study to investigate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of UGN-501, a chimeric oncolytic adenovirus, administered intravesically in participants with recurrent NMIBC.\n\nEligible participants will enter a 12-week Induction Period. Participants with Ta and\u002For T1 disease who do not have disease recurrence, and participants with carcinoma in situ (CIS) who have a complete response (CR) at Week 12, will enter the Maintenance Period. Disease assessments will be performed every 3 months through Month 15, or until disease recurrence, disease progression, or death, whichever occurs first.\n\nThe maximum duration of participation is approximately 15 months.\n\nThis master protocol may include multiple study intervention arms designed to independently evaluate UGN-501. Any additional study intervention arms or dose expansions will be added by protocol amendment.",[19,20,21,22,23,24,25,26],"Bladder (Urothelial, Transitional Cell) Cancer","NMIBC","Urothelial Carcinoma Bladder","Urothelial Carcinoma in Situ","Urothelial Carcinoma Recurrent","Urothelial Carcinoma of the Urinary Bladder","Non-Muscle Invasive Bladder Carcinoma","Non-muscle Invasive Bladder Cancer (NMIBC)",[28,29,30,31,32,33,34,35],"CIS","Ta bladder cancer","T1 bladder cancer","BCG-unresponsive NMIBC","BCG-exposed NMIBC","BCG-intolerant NMIBC","Intravesical therapy","Oncolytic Virus","INTERVENTIONAL","TREATMENT",[39],"PHASE1",{"count":41,"type":42},30,"ESTIMATED",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48},"BIOLOGICAL","UGN-501","UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12.",[49],"UGN-501 Dose Escalation (Part 1)",[51,55,59,63],{"measure":52,"description":53,"timeFrame":54},"Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)","The number of participants with each type of event will be summarized.","Up to 15 Months",{"measure":56,"description":57,"timeFrame":58},"Concentration of UGN-501 in blood and urine","Data will be summarized using descriptive statistics.","Up to 12 Weeks",{"measure":60,"description":61,"timeFrame":62},"Complete response rate (CRR)","CRR is defined as the proportion of CIS participants who achieved CR at the Week 12 (3-month) Visit.","3 Months",{"measure":64,"description":65,"timeFrame":66},"Recurrence-free survival (RFS) rate","RFS rate is defined as the proportion of participants with Ta\u002FT1 disease who are recurrence-free at the 6-month Visit.","6 Months",[68,71,74,76,78,80,82],{"measure":69,"description":70,"timeFrame":58},"Presence of anti-drug antibodies (ADA) in serum","The number of participants with ADA will be summarized.",{"measure":72,"description":73,"timeFrame":58},"UGN-501 maximum concentration (Cmax) following single and repeat dose administration","Data will be summarized using descriptive statistics",{"measure":75,"description":57,"timeFrame":58},"UGN-501 area under the concentration-time curve (AUC) following single and repeat dose administration",{"measure":77,"description":57,"timeFrame":58},"UGN-501 terminal half-life (t1\u002F2) following single and repeat dose administration",{"measure":79,"description":57,"timeFrame":58},"UGN-501 time to maximum concentration (tmax) following single and repeat dose administration",{"measure":81,"description":57,"timeFrame":58},"UGN-501 concentration at the end of a dosing interval (Ctau) following single and repeat dose administration",{"measure":83,"description":57,"timeFrame":58},"Evaluation of viral shedding in urine following singe and repeat dose administration.","ALL","18 Years",null,{"inclusion":88,"exclusion":109,"raw_text":110},[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"Has BCG-unresponsive disease, defined as:","persistent or recurrent CIS alone or with recurrent Ta\u002FT1 disease within 12 months of completion of adequate BCG therapy; or","recurrent high-grade Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy; or","high-grade T1 disease at the first evaluation following a BCG induction course.","Is BCG-exposed, defined as high-grade persistent or recurrent NMIBC within 24 months of the last dose of BCG but not meeting the definition of BCG-unresponsive disease, and received at least 5 of 6 doses of an initial induction course of BCG.","Is BCG intolerant, defined as the inability to tolerate at least 1 full induction course of BCG.","Has a high-grade Ta tumor ≤3 cm and failed at least 1 previous course of therapy, such as TURBT plus an adjuvant induction course of intravesical chemotherapy. 4. Participants with low-grade disease must meet one of the following criteria:","Ta tumors recurring within 1 year.","Ta solitary tumor \\>3 cm.","Ta multifocal tumors.","T1 tumors. 5. All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments. 6. Has Eastern Cooperative Oncology Group performance status score ≤2. 7. Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and\u002For epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma. 8. Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen \\\u003C20 ng\u002FdL, and cT1-cT2b, at the discretion of the investigator. 9. Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:","Leukocytes ≥3000\u002FμL.","Absolute neutrophil count ≥1500\u002FμL.","Platelets ≥100,000\u002FμL.","Hemoglobin ≥9.0 g\u002FdL.","Total bilirubin ≤1.5 × upper limit of normal (ULN).","Aspartate aminotransferase (AST) ≤2.5 × UL","Alanine aminotrasferase (ALT) ≤2.5 × ULN.","Alkaline phosphatase ≤2.5 × ULN.","Estimated creatinine clearance ≥30 mL\u002Fmin using the Cockcroft-Gault equation. 10. Has a life expectancy \\>12 months. 11. Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation. 12. Has signed informed consent and is willing and able to comply with the requirements and restrictions listed in the informed consent form and protocol.",[],"Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing informed consent.\n2. Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and\u002For T1 disease and\u002For carcinoma in situ (CIS), or recurrent low-grade Ta and\u002For T1 disease.\n3. Participants with high-grade Ta and\u002For T1 disease and\u002For CIS must meet one of the following criteria:\n\n   * Has BCG-unresponsive disease, defined as:\n   * persistent or recurrent CIS alone or with recurrent Ta\u002FT1 disease within 12 months of completion of adequate BCG therapy; or\n   * recurrent high-grade Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy; or\n   * high-grade T1 disease at the first evaluation following a BCG induction course.\n\n   Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Participants with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.\n   * Is BCG-exposed, defined as high-grade persistent or recurrent NMIBC within 24 months of the last dose of BCG but not meeting the definition of BCG-unresponsive disease, and received at least 5 of 6 doses of an initial induction course of BCG.\n   * Is BCG intolerant, defined as the inability to tolerate at least 1 full induction course of BCG.\n   * Has a high-grade Ta tumor ≤3 cm and failed at least 1 previous course of therapy, such as TURBT plus an adjuvant induction course of intravesical chemotherapy.\n4. Participants with low-grade disease must meet one of the following criteria:\n\n   * Ta tumors recurring within 1 year.\n   * Ta solitary tumor \\>3 cm.\n   * Ta multifocal tumors.\n   * T1 tumors.\n5. All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments.\n6. Has Eastern Cooperative Oncology Group performance status score ≤2.\n7. Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and\u002For epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma.\n8. Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen \\\u003C20 ng\u002FdL, and cT1-cT2b, at the discretion of the investigator.\n9. Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:\n\n   * Leukocytes ≥3000\u002FμL.\n   * Absolute neutrophil count ≥1500\u002FμL.\n   * Platelets ≥100,000\u002FμL.\n   * Hemoglobin ≥9.0 g\u002FdL.\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN).\n   * Aspartate aminotransferase (AST) ≤2.5 × UL\n   * Alanine aminotrasferase (ALT) ≤2.5 × ULN.\n   * Alkaline phosphatase ≤2.5 × ULN.\n   * Estimated creatinine clearance ≥30 mL\u002Fmin using the Cockcroft-Gault equation.\n10. Has a life expectancy \\>12 months.\n11. Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation.\n12. Has signed informed consent and is willing and able to comply with the requirements and restrictions listed in the informed consent form and protocol.\n\nExclusion Criteria:\n\n1. Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma, including T2, T3, T4, and\u002For stage IV disease.\n2. Current systemic therapy for bladder cancer.\n3. Prior treatment with any human adenovirus-based therapy, such as nadofaragene firadenovec-vncg or cretostimogene grenadenorepvec.\n4. Intravesical therapy within 4 weeks before starting study intervention, including but not limited to BCG, chemotherapy, and nogapendekin alfa inbakicept.\n5. Participation in a study of an investigational agent with receipt of study therapy, or receipt of an investigational device, within 4 weeks before the first dose of study intervention.\n6. Receipt of immune modulator therapy within 5 half-lives of starting study intervention, including but not limited to pembrolizumab, BCG, and nogapendekin alfa inbakicept.\n7. Receipt of a vaccine or anti-viral agent within 2 weeks before starting study intervention.\n8. Active infection requiring systemic therapy, including urinary tract infection. Participants may enter the study once the infection is satisfactorily treated.\n9. Immunocompromised state, including but not limited to HIV infection or any condition that required systemic immunosuppressive treatment in the past 2 years, such as active systemic autoimmune disease or solid organ or stem cell transplant. Short courses (≤14 days) of steroids for medical reasons without anticancer intent, such as atopic dermatitis, psoriasis, infection, or allergic reaction, are permitted if the last dose was at least 4 weeks before the first dose of study intervention.\n10. Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the investigator, would preclude participation in the study.\n11. History of malignancy of another organ system within the past 5 years, except previously treated UTUC, basal cell carcinoma or squamous cell carcinoma of the skin, and\u002For prostate cancer meeting protocol-specified criteria.\n12. Cannot tolerate intravesical dosing or intravesical surgical manipulation.\n13. Known allergy or hypersensitivity to any of the study interventions or any study intervention excipients.",[112,113],"ADULT","OLDER_ADULT",[115,133,148,163,178,193,207,221,236,250,265],{"facility":116,"city":117,"state":118,"zip":119,"country":120,"contacts":121,"geoPoint":130},"East Valley Urology Center of Arizona","Queen Creek","Arizona","85140","United States",[122,127],{"name":123,"role":124,"phone":125,"email":126},"Alekya Padavala","CONTACT","480-525-7998","apadavala@folioresearch.com",{"name":128,"role":129},"Harpreet Wadhwa, MD","PRINCIPAL_INVESTIGATOR",{"lat":131,"lon":132},33.24866,-111.6343,{"facility":134,"city":135,"state":136,"zip":137,"country":120,"contacts":138,"geoPoint":145},"Michael G Oefelein Clinical Trials","Bakersfield","California","93301",[139,143],{"name":140,"role":124,"phone":141,"email":142},"Chloe Caldasso","661-310-1063","CCaldasso@folioclinicalresearch.com",{"name":144,"role":129},"Michael Oefelein, MD",{"lat":146,"lon":147},35.37329,-119.01871,{"facility":149,"city":150,"state":136,"zip":151,"country":120,"contacts":152,"geoPoint":160},"Urology Center of Southern California","Murrieta","92563",[153,158],{"name":154,"role":124,"phone":155,"phoneExt":156,"email":157},"Laura Guerrero","951-677-3000","309","lguerrero@folioclinicalresearch.com",{"name":159,"role":129},"Madhumitha Reddy, DO",{"lat":161,"lon":162},33.55391,-117.21392,{"facility":164,"city":165,"state":166,"zip":167,"country":120,"contacts":168,"geoPoint":175},"Brigham and Women's Hospital","Boston","Massachusetts","02115",[169,173],{"name":170,"role":124,"phone":171,"email":172},"Nnamdi Onnochie","857-221-2468","Nnamdi_Onochie@dfci.harvard.edu",{"name":174,"role":129},"Matthew Mossanen, MD, PhD",{"lat":176,"lon":177},42.35843,-71.05977,{"facility":179,"city":180,"state":181,"zip":182,"country":120,"contacts":183,"geoPoint":190},"University of Nebraska Medical Center","Omaha","Nebraska","68198",[184,188],{"name":185,"role":124,"phone":186,"email":187},"Kacie Flaherty","402-559-3834","kacie.flaherty@unmc.edu",{"name":189,"role":129},"Jared Schober, MD",{"lat":191,"lon":192},41.25626,-95.94043,{"facility":194,"city":195,"state":195,"zip":196,"country":120,"contacts":197,"geoPoint":204},"Ichan School of Medicine at Mount Sinai","New York","10029",[198,202],{"name":199,"role":124,"phone":200,"email":201},"Harshil Sardhara","908-449-1437","harshil.sardhara@mountsinai.org",{"name":203,"role":129},"John Sfakianos, MD",{"lat":205,"lon":206},40.71427,-74.00597,{"facility":208,"city":209,"state":195,"zip":210,"country":120,"contacts":211,"geoPoint":218},"SUNY Upstate Medical University","Syracuse","13210",[212,216],{"name":213,"role":124,"phone":214,"email":215},"Nicholas Carusone","315-464-5296","carusonn@upstate.edu",{"name":217,"role":129},"Joseph Jacob, MD",{"lat":219,"lon":220},43.04812,-76.14742,{"facility":222,"city":223,"state":224,"zip":225,"country":120,"contacts":226,"geoPoint":233},"University of Pennsylvania-Perelman Center for Advanced Medicine","Philadelphia","Pennsylvania","19104",[227,231],{"name":228,"role":124,"phone":229,"email":230},"Ryan DeBarberie","215-615-3780","ryan.debarberie@pennmedicine.upenn.edu",{"name":232,"role":129},"Trinity Bivalacqua, MD, PhD",{"lat":234,"lon":235},39.95238,-75.16362,{"facility":237,"city":238,"state":239,"zip":240,"country":120,"contacts":241,"geoPoint":247},"START Carolinas","Myrtle Beach","South Carolina","29572",[242,245],{"role":124,"phone":243,"email":244},"843-839-1679","hopeteam@startresearch.com",{"name":246,"role":129},"Abhishek Srivastava, MD",{"lat":248,"lon":249},33.68906,-78.88669,{"facility":251,"city":252,"state":253,"zip":254,"country":120,"contacts":255,"geoPoint":262},"UPNT Research Institute","Arlington","Texas","76017",[256,260],{"name":257,"role":124,"phone":258,"email":259},"Keoisha Malone","615-523-9624","Keoisha.malone@objective.health",{"name":261,"role":129},"Patrick Collini, MD",{"lat":263,"lon":264},32.73569,-97.10807,{"facility":266,"city":267,"state":253,"zip":268,"country":120,"contacts":269,"geoPoint":276},"Urology Austin","Austin","78759",[270,274],{"name":271,"role":124,"phone":272,"email":273},"Stephanie Sova","512-788-9688","stephanie.sova@urologyaustin.com",{"name":275,"role":129},"Brian Mazzarella, MD",{"lat":277,"lon":278},30.26715,-97.74306,[280],{"name":281,"role":124,"phone":282,"email":283},"Heather Lansford","610-226-5111","heather.lansford@urogen.com",[285],{"name":286,"affiliation":287,"role":288},"Sebastian Mirkin, MD","UroGen Pharma","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":292,"biomarkers":294},[25,293],"Stage 0 Transitional Cell Carcinoma",[],{"nct_id":4,"found":296,"summary":297,"prompt_version":307},true,{"design":298,"status":299,"heading":300,"summary":301,"follow_up":302,"word_count":303,"commitments":304,"compensation":305,"drugs_mentioned":306},"This is a Phase 1, open-label study, meaning you and your doctors will know you are receiving UGN-501. It is a dose-escalation study, planning to enroll about 30 participants.","completed","Phase 1 Study of UGN-501 for Recurrent Non-Muscle Invasive Bladder Cancer","This study is testing a new treatment called UGN-501 for adults with recurrent non-muscle invasive bladder cancer (NMIBC). UGN-501 is given directly into the bladder. The main goals are to find out how safe UGN-501 is, what side effects it might cause, and to determine the best dose for future studies. Researchers will also look at how much UGN-501 is in your blood and urine, and if it helps to clear the cancer. You might be able to join if you are 18 or older and have confirmed recurrent NMIBC, including high-grade or low-grade disease, or carcinoma in situ (CIS). The study is currently unclear on its recruitment status.","You will be followed for safety and side effects for up to 15 months. Researchers will also measure UGN-501 levels in your blood and urine for up to 12 weeks.",109,"You would receive UGN-501 instilled into your bladder weekly for 6 weeks. If eligible, you might then receive 3 weekly instillations every three months for up to a year. You will have disease assessments every 3 months for up to 15 months.","Not stated in the trial record.",[46],"v2"]