Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

NCT05704244 | Active Not Recruiting Phase 3

• 1 other identifier: 000381
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 24

Brief Summary

To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Whether or not a subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) responds to treatment, defined as complete response at any time after first administration of FE 999326

  A subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) has achieved a complete response at an efficacy assessment if urine cytology is negative and there are no lesions on cystoscopy. If biopsy of the bladder is performed, this must be negative.

  At Month 12 assessment

Secondary Outcomes (8)

• Duration of complete response in subjects with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who show a complete response at any time after first administration of FE 999326

  Up to 5 years

• Whether or not a subject with high-grade Ta or T1 papillary disease (without concomitant CIS) responds to treatment, defined as absence of recurrence of high-grade disease

  Up to 4 years

• Duration of event-free survival in subjects with high-grade Ta or T1 papillary disease (without concomitant CIS) and in subjects with CIS (with or without papillary disease)

  Up to 5 years

• Incidence of cystectomy

  Up to 4 years

• Time to cystectomy

  Up to 4 years

Study Arms (1)

FE 999326

EXPERIMENTAL

Drug: FE 999326

Interventions

FE 999326 DRUG

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

Also known as: nadofaragene firadenovec

FE 999326

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at entry, confirmed by a pathology report:
• Carcinoma in situ (CIS) only
• Ta/T1 high-grade disease with concomitant CIS or
• Ta/T1 high-grade disease without concomitant CIS
• Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
• Life expectancy \>2 years, in the opinion of the investigator
• Eastern Cooperative Oncology Group (ECOG) status 2 or less
• Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra
• Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \<10 ng/dL

You may not qualify if:

• Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit.
• Current systemic therapy for bladder cancer
• Current or prior investigational treatment for BCG unresponsive NMIBC or any other investigational drug within 1 month prior to screening
• Current or prior pelvic external beam radiotherapy within 5 years of entry
• Use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before and after instillation
• History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy.
• Subjects who cannot hold instillation for 1 hour
• Subjects who cannot tolerate intravesical dosing or intravesical surgical manipulation
• Intravesical therapy within 8 weeks prior to beginning trial treatment, with the exception of:
• Cytotoxic agents when administered as a single instillation immediately following a TURBT procedure
• Previous intravesical BCG therapy
• Systemic immunosuppressive therapy within 3 months prior to screening

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (24)

Ferring Investigational Site

Nagakute-shi, Aichi-ken, Japan

Location

Ferring Investigational Site

Nagoya, Aichi-ken, Japan

Location

Ferring Investigational Site

Narita-shi, Chiba, Japan

Location

Ferring Investigational Site

Matsuyama, Ehime, Japan

Location

Ferring Investigational Site

Fukuoka, Fukuoka, Japan

Location

Ferring Investigational Site

Hiroshima, Hiroshima, Japan

Location

Ferring Investigational Site

Hakodate-shi, Hokkaido, Japan

Location

Ferring Investigational Site

Sapporo, Hokkaido, Japan

Location

Ferring Investigational Site

Hitachi-shi, Ibaraki, Japan

Location

Ferring Investigational Site

Tsukuba, Ibaraki, Japan

Location

Ferring Investigational Site

Kawasaki-shi, Kanagawa, Japan

Location

Ferring Investigational Site

Yokohama, Kanagawa, Japan

Location

Ferring Investigational Site

Nankoku-shi, Kochi, Japan

Location

Ferring Investigational Site

Tsu, Mie-ken, Japan

Location

Ferring Investigational Site

Sendai, Miyagi, Japan

Location

Ferring Investigational Site

Matsumoto-shi, Nagano, Japan

Location

Ferring Investigational Site

Kashihara-shi, Nara, Japan

Location

Ferring Investigational Site

Okayama, Okayama-ken, Japan

Location

Ferring Investigational Site

Takatsuki-shi, Osaka, Japan

Location

Ferring Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Ferring Investigational Site

Minato-ku, Tokyo, Japan

Location

Ferring Investigational Site

Mitaka-shi, Tokyo, Japan

Location

Ferring Investigational Site

Toyama, Toyama, Japan

Location

Ferring Investigational Site

Wakayama, Wakayama, Japan

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 30, 2023
• Study Start: December 21, 2022
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (24)