Actively Recruiting
Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
235
Participants Needed
59
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of the Erdafitinib intravesical delivery system in participants with non-muscle-invasive or muscle-invasive bladder cancer that have activating FGFR mutations or fusions. The study includes several parts: dose escalation to find the recommended Phase 2 dose, dose expansion to assess preliminary clinical efficacy, and further dose expansion to confirm safety and activity. The final phase focuses on assessing complete response in participants with intermediate-risk non-muscle-invasive bladder cancer, a condition where cancer cells are confined to the bladder's inner lining. Participants receive Erdafitinib delivered directly into the bladder through a specialized system designed to target localized bladder cancer while reducing side effects often seen with oral treatment. The study includes four parts: dose escalation to identify safe doses, dose expansion across different disease cohorts to evaluate safety and pharmacokinetics, RP2D dose expansion to further assess safety and preliminary activity, and a phase 2 expansion focusing on intermediate-risk NMIBC. Treatment is given according to disease type and dose level, with ongoing monitoring throughout. During the study, participants undergo screening, treatment, and follow-up phases lasting up to about 7 years and 4 months. Researchers monitor adverse events, dose-limiting toxicities, and clinical responses such as complete response rates and recurrence-free survival. Assessments include measuring Erdafitinib levels in plasma and urine, quality of life questionnaires, and tumor evaluations. Safety is closely tracked, and participants are regularly evaluated for treatment effects and disease status throughout the study period.
CONDITIONS
Brief Title
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with muscle-invasive or recurrent non-muscle-invasive urothelial carcinoma of the bladder
- Have activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion confirmed by approved local or central testing
- For certain cohorts, must be Bacillus Calmette-Guérin (BCG) experienced or have no BCG experience due to unavailability within the last 2 years
- For cohort 1, must refuse or be ineligible for radical cystectomy
- For cohorts 2 and 4, must be willing and eligible for radical cystectomy
- For part 4, histologically confirmed 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 biopsy allowed if tumor remains at least 5 mm
- Must submit tissue and urine for FGFR testing
- Prior or concurrent second malignancy allowed if unlikely to interfere with study endpoints
You will not qualify if you...
- Presence of transitional cell carcinoma outside the bladder (urethra, ureter, renal pelvis)
- Previous treatment with a pan-FGFR inhibitor
- Received pelvic radiotherapy within 6 months before starting study treatment unless no radiation cystitis is present
- Any bladder or urethral anatomical feature preventing safe use of Erdafitinib intravesical delivery system
- Having an indwelling urinary catheter (intermittent catheterization allowed)
- For part 4, diagnosis of T1 NMIBC, high-risk NMIBC, locally advanced non-resectable or metastatic urothelial carcinoma prior to enrollment
- Known allergies or intolerance to study components
- Current diagnosis of newly diagnosed IR-NMIBC
- Received investigational treatment for bladder cancer after recent bladder tumor resection within 4 weeks or washout period
- Evidence of current bladder perforation by cystoscopy or imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 7 years 4 months
Participants receive Erdafitinib intravesical delivery system to treat localized bladder cancer.
Visits scheduled throughout treatment period according to cohort and dose escalation or expansion phase
Duration - Up to approximately 7 years 4 months
Participants are monitored for safety, treatment response, and long-term outcomes after treatment ends.
Periodic visits for up to 7 years 4 months after treatment completion
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
Completed
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
Active, Not Recruiting
33
Marien hospital Herne
Herne, Germany, 44625
Completed
34
Urologie Neandertal Praxis Mettmann
Mettmann, Germany, 40822
Active, Not Recruiting
35
Universitatsklinikum Munster
Münster, Germany, 48149
Completed
36
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Completed
37
Rambam Medical Center
Haifa, Israel, 3109601
Active, Not 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
Active, Not 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
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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