Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Last Updated May 14, 2025

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CR109115

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1
Sites
25 Sites
Status

Recruiting

SUMMARY

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 11 months.

CONDITIONS

Bladder Cancer
Receptors, Fibroblast Growth Factor

ELIGIBILITY

Inclusion Criteria:

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

Exclusion Criteria:

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
* Known allergies, hypersensitivity, or intolerance to any study component or its excipients
* Has a current diagnosis of primary 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

Inclusion Criteria:

Parts 1-3:

More...

DETAILS

LOCATIONS

Locations in:

United States, Germany, South Korea, Netherlands, Spain

Country (5)	City or Province (25)	Status
United States	Los Angeles University of Southern California	RECRUITING
United States	Tampa H Lee Moffitt Cancer Center	RECRUITING
United States	Chicago Northwestern University	RECRUITING
United States	Charlotte Levine Cancer Institute, Carolinas HealthCare System	RECRUITING
United States	Myrtle Beach Carolina Urologic Research Center	RECRUITING
United States	Nashville Urology Associates	RECRUITING
United States	San Antonio Urology San Antonio Research	RECRUITING
Germany	Frankfurt am Main Universitatsklinikum Frankfurt	RECRUITING
Germany	Herne Marien hospital Herne	RECRUITING
Germany	Münster Universitatsklinikum Munster	RECRUITING
Germany	Ulm Universitaetsklinikum Ulm	RECRUITING
South Korea	Goyang-Si National Cancer Center	RECRUITING
South Korea	Gwangju Chonnam National University Hospital	RECRUITING
South Korea	Seoul Seoul National University Hospital	RECRUITING
South Korea	Seoul The Catholic University of Korea Seoul St Marys Hospital	RECRUITING
Netherlands	Nijmegen Radboud Umcn	COMPLETED
Netherlands	Utrecht UMC Utrecht	COMPLETED
Spain	Barcelona Fund. Puigvert	COMPLETED
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Madrid Hosp. Univ. 12 de Octubre	RECRUITING
United States	Hialeah Urological Research Network	RECRUITING
United States	Chicago Ridge Associated Urological Specialists	RECRUITING
United States	Greenwood Urology of Indiana	RECRUITING
United States	North Charleston Low Country Urology Clinics	RECRUITING

Geo Locations

34.05223, -118.24368

27.94752, -82.45843

41.85003, -87.65005

35.22709, -80.84313

33.68906, -78.88669

36.16589, -86.78444

29.42412, -98.49363

50.11552, 8.68417

51.5388, 7.22572

51.96236, 7.62571

48.39841, 9.99155

37.65639, 126.835

35.15472, 126.91556

37.566, 126.9784

51.8425, 5.85278

52.09083, 5.12222

41.38879, 2.15899

40.4165, -3.70256

25.8576, -80.27811

41.70142, -87.77922

39.61366, -86.10665

32.85462, -79.97481

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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