OncoMatch/Clinical Trials/NCT05316155
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Is NCT05316155 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Erdafitinib Intravesical Delivery System for non-muscle invasive bladder neoplasms.
Treatment: Erdafitinib Intravesical Delivery System — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Allowed: FGFR1 activating mutation
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR2 activating mutation
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR3 activating mutation
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR4 activating mutation
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR1 fusion
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR2 fusion
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR3 fusion
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Allowed: FGFR4 fusion
Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing
Disease stage
Required: Stage NON-MUSCLE-INVASIVE, MUSCLE-INVASIVE, TA LG
Excluded: Stage HR NMIBC (HG/G2 OR HG/G3 OR CIS), MIBC, III, NON-RESECTABLE, IV
Grade: low grade (LG)
Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors; Excluded: T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS), MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma
Prior therapy
Cannot have received: pan-fibroblast growth factor receptor (FGFR) inhibitor
Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
Cannot have received: pelvic radiotherapy
Exception: allowed if >6 months prior to study treatment and no cystoscopic evidence of radiation cystitis
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
Cannot have received: investigational treatment for bladder cancer
Exception: allowed if before TURBT for current NMIBC diagnosis and >4 weeks or agent/therapy washout period before first dose
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham - The Kirklin Clinic · Birmingham, Alabama
- University of Southern California · Los Angeles, California
- Urology Associates of Denver · Lone Tree, Colorado
- Urological Research Network · Hialeah, Florida
- Advanced Urology Institute · Largo, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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