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Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

NCT05316155

Active Not RecruitingPhase 1, Phase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Non-Muscle Invasive Bladder Neoplasms

Interventions: Erdafitinib Intravesical Delivery System

Countries: United States, Canada, Germany, Israel, Japan, Netherlands, South Korea, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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. 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
Locations (59)
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Lone Tree, Colorado, United States
  • Hialeah, Florida, United States
  • Largo, Florida, United States
  • Orlando, Florida, United States
  • Oxford, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Chicago Ridge, Illinois, United States
  • Greenwood, Indiana, United States
  • Merrillville, Indiana, United States
  • Lexington, Kentucky, United States
  • Lafayette, Louisiana, United States
  • Plymouth, Massachusetts, United States
  • St Louis, Missouri, United States
  • Hackensack, New Jersey, United States
  • Syracuse, New York, United States
  • Charlotte, North Carolina, United States
  • Gahanna, Ohio, United States
  • Myrtle Beach, South Carolina, United States
  • North Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • Vancouver, British Columbia, Canada
  • Halifax, Nova Scotia, Canada
  • Hamilton, Ontario, Canada
  • Toronto, Ontario, Canada
  • Dresden, Germany
  • + 29 more on CT.gov