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

• Status: Not yet recruiting
• Trial end date: 2026-10-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

Criteria

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

• At least 1 of the study protocol defined activating tumor fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing

• Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (<=) 2

• A female participant of childbearing potential must have a negative serum test at screening and a negative urine test (or serum test if required by local regulations) within 72 hours of the first dose (that is, first insertion) of study treatment, and must agree to further serum or urine pregnancy tests during the study

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

• Toxicity from prior anticancer therapy has not resolved to baseline levels or to grade less than or equal to [<=] 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be grade 2)