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La Paz","28046",{"type":54,"coordinates":577},[564,565],{"lat":565,"lon":564},{"facility":580,"status":294,"city":581,"state":43,"zip":582,"country":531,"cosmosGeoPoint":583,"geoPoint":587,"contacts":43},"Instituto Valenciano de Oncologia","Valencia","46009",{"type":54,"coordinates":584},[585,586],-0.37966,39.47391,{"lat":586,"lon":585},{"type":589,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100463550",false,"NCT05316155","Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer","Phase 1\u002F2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\nParts 1-3:\n\n* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder\n* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests\n* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible\n* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)\n* Cohorts 2 and 4: Willing and eligible for RC\n\nPart 4:\n\n* Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors\n* Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size\n* Must submit tissue and urine for FGFR testing\n* Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment\n\nExclusion Criteria:\n\nParts 1-3:\n\n* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium\n* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor\n* Received pelvic radiotherapy \\\u003C=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis\n* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system\n* Indwelling urinary catheter. Intermittent catheterization is acceptable\n\nPart 4:\n\n* Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG\u002FG2 or HG\u002FG3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\\>=5) years ago and there is documentation of low grade (LG) Ta thereafter\n* Known allergies, hypersensitivity, or intolerance to any study component or its excipients\n* Has a current diagnosis of newly diagnosed IR-NMIBC\n* Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent\u002Ftherapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study\n* Evidence of current bladder perforation by cystoscopy or imaging","ALL","18 Years",{"count":599,"type":600},235,"ESTIMATED","INTERVENTIONAL",[603,604],"PHASE1","PHASE2","The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\\[s\\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).",[607],"Non-Muscle Invasive Bladder Neoplasms",[609,610],"Non-Muscle Invasive Bladder Cancer (NMIBC)","Muscle Invasive Bladder Cancer (MIBC)","2026-06-04",{"date":613,"type":614},"2026-06-05","ACTUAL",{"date":616,"type":614},"2022-04-11",{"date":618,"type":600},"2029-07-24",{"name":5,"class":6},59]