Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05316155

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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