Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
NCT05704244 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-08-28
Summary
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.
Conditions
Interventions
- DRUG
-
FE 999326
75 mL FE 999326 (3 x 10\^11 vp/mL) of sterile suspension instilled once every 3 months into the bladder via a urinary catheter
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Global Clinical Compliance · Ferring Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-21
- Primary Completion
- 2029-11-30
- Completion
- 2029-11-30
Countries
- Japan
Study Locations
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