Clinical trial · Interventional
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or Fusions
NCT05567185CI-TRIAL-00124529TAR-210active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Receptors, Fibroblast Growth Factor | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erdafitinib Intravesical Delivery System | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation: Erdafinitib Intravesical Delivery System
- description
- 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.
- interventionNames
- Drug: Erdafitinib Intravesical Delivery System
Primary outcomes (1)
- measure
- Number of Participants with Dose-limiting Toxicity (DLT)
- timeFrame
- Up to 28 days
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.