A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (TAR-210)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 1

Conditions: Urinary Bladder Neoplasms; Receptors, Fibroblast Growth Factor

Treatments: Drug: Erdafitinib Intravesical Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05567185

CR109248

42756493BLC1004 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Dose Escalation: Erdafinitib Intravesical Delivery System

Experimental group

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.

Treatment:

Drug: Erdafitinib Intravesical Delivery System