Actively Recruiting
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
235
Participants Needed
59
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
Parts 1-3:
- Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
- 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
- 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
- Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
- Cohorts 2 and 4: Willing and eligible for RC
Part 4:
- Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
- 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
- Must submit tissue and urine for FGFR testing
- 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
You will not qualify if you...
Parts 1-3:
- Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
- Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
- Received pelvic radiotherapy <=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
- 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
- Indwelling urinary catheter. Intermittent catheterization is acceptable
Part 4:
- Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 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
- Known allergies, hypersensitivity, or intolerance to any study component or its excipients
- Has a current diagnosis of newly diagnosed IR-NMIBC
- 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/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study
- Evidence of current bladder perforation by cystoscopy or imaging
AI-Screening
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Trial Site Locations
Total: 59 locations
1
University of Alabama at Birmingham - The Kirklin Clinic
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
Urology Associates of Denver
Lone Tree, Colorado, United States, 80124
Actively Recruiting
4
Urological Research Network
Hialeah, Florida, United States, 33016
Actively Recruiting
5
Advanced Urology Institute
Largo, Florida, United States, 33771
Actively Recruiting
6
Advent Health Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
7
Advanced Urology Institute 1
Oxford, Florida, United States, 34484
Completed
8
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
9
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
11
Urology of Indiana
Greenwood, Indiana, United States, 46143
Actively Recruiting
12
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, United States, 46410
Actively Recruiting
13
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
14
Southern Urology LLC
Lafayette, Louisiana, United States, 70508
Actively Recruiting
15
Greater Boston Urology
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
16
Specialty Clinical Research of St Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
17
Hackensack University Medical Center Urology
Hackensack, New Jersey, United States, 07601
Actively Recruiting
18
Associated Medical Professionals
Syracuse, New York, United States, 13210
Actively Recruiting
19
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, United States, 28204
Completed
20
Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
21
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
22
Low Country Urology Clinics
North Charleston, South Carolina, United States, 29406
Actively Recruiting
23
Urology Associates
Nashville, Tennessee, United States, 37209
Actively Recruiting
24
Urology Austin
Austin, Texas, United States, 78745
Actively Recruiting
25
Urology San Antonio Research
San Antonio, Texas, United States, 78229
Completed
26
Vancouver Prostate Centre Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Active, Not Recruiting
27
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Active, Not Recruiting
28
St Josephs Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Active, Not Recruiting
29
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Completed
30
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Completed
31
Urologicum Duisburg
Duisburg, Germany, 47169
Completed
32
Universitatsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
33
Marien hospital Herne
Herne, Germany, 44625
Actively Recruiting
34
Urologie Neandertal Praxis Mettmann
Mettmann, Germany, 40822
Actively Recruiting
35
Universitatsklinikum Munster
Münster, Germany, 48149
Completed
36
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
37
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
38
Carmel Medical Center
Haifa, Israel, 3436212
Active, Not Recruiting
39
Rabin Medical Center
Petah Tikva, Israel, 4941492
Active, Not Recruiting
40
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
41
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810 8563
Active, Not Recruiting
42
Yamanashi Prefectural Central Hospital
Kofu, Japan, 400-8506
Active, Not Recruiting
43
Osaka General Medical Center
Osaka, Japan, 558-8558
Active, Not Recruiting
44
Toyama University Hospital
Toyama, Japan, 930 0194
Active, Not Recruiting
45
Radboud Umcn
Nijmegen, Netherlands, 6525 GA
Completed
46
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Completed
47
National Cancer Center
Goyang-si, South Korea, 10408
Completed
48
Chonnam National University Hospital
Gwangju, South Korea, 61469
Active, Not Recruiting
49
Seoul National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
50
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Active, Not Recruiting
51
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Completed
52
Fund. Puigvert
Barcelona, Spain, 08025
Completed
53
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Active, Not Recruiting
54
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Active, Not Recruiting
55
Hosp Reina Sofia
Córdoba, Spain, 14004
Active, Not Recruiting
56
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Active, Not Recruiting
57
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Active, Not Recruiting
58
Hosp. Univ. La Paz
Madrid, Spain, 28046
Active, Not Recruiting
59
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Active, Not Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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