A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

NCT05567185 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: CR10924842756493BLC1004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.

Conditions

Receptors, Fibroblast Growth Factor; Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Dose-limiting Toxicity (DLT)

  Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

  Up to 28 days

Secondary Outcomes (4)

• Plasma Concentration of Erdafitinib

  Up to 180 days

• Urine Concentration of Erdafitinib

  Up to 180 days

• Number of Participants with Adverse Events (AEs)

  Up to 3 years 10 months

• Number of Participants with AEs by Severity

  Up to 3 years 10 months

Study Arms (1)

Dose Escalation: Erdafinitib Intravesical Delivery System

EXPERIMENTAL

Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent.

Drug: Erdafitinib Intravesical Delivery System

Interventions

Erdafitinib Intravesical Delivery System DRUG

Erdafitinib intravesical delivery system will be administered.

Also known as: JNJ-42756493

Dose Escalation: Erdafinitib Intravesical Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder
• All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy
• Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) after prior therapy that meet either one: a. Recurrence of high-risk NMIBC (high-grade Ta or any-grade T1) within 12 months after adequate Bacillus Calmette-Guerin (BCG), or any-grade T1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (RC). b. Recurrence of intermediate- or high-risk NMIBC (any-grade Ta/T1) after prior BCG regardless of the timing of recurrence, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing BCG treatment
• At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (TURBT)
• Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (\<=) 2

You may not qualify if:

• Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder.
• Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor
• Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system
• Participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment
• Participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -Bladder post-void residual volume (PVR) \>350 mL after second voided urine, -Current central serous retinopathy or retinal pigment epithelial detachment of any-grade

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (4)

St Marianna University Hospital

Kanagawa, 216 8511, Japan

Location

Osaka International Cancer Institute

Osaka, 541 8567, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

University of Tsukuba Hospital

Tsukuba, 305 8576, Japan

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Acrocephalosyndactylia

Interventions

erdafitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: March 3, 2023
• Primary Completion: March 11, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (4)