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

Bladder Cancer Clinical Trial

Official title:

A Phase 3, Open Label Trial to Evaluate the Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704244
• Other study ID #: 000381
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2022
• Est. completion date: December 27, 2029

Study information

• Verified date: June 2024
• Source: Ferring Pharmaceuticals
• Contact: Global Clinical Compliance
• Phone: +1 833-548-1402 (US/Canada)
• Email: DK0-Disclosure[@]ferring.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 27, 2029
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Have at entry, confirmed by a pathology report:

1. Carcinoma in situ (CIS) only

2. Ta/T1 high-grade disease with concomitant CIS or

3. 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Ferring Investigational Site	Bunkyo-ku	Tokyo
Japan	Ferring Investigational Site	Fukuoka-shi	Fukuoka
Japan	Ferring Investigational Site	Hakodate-shi	Hokkaido
Japan	Ferring Investigational Site	Hiroshima-shi	Hiroshima
Japan	Ferring Investigational Site	Hitachi-shi	Ibaraki
Japan	Ferring Investigational Site	Kashihara-shi	Nara
Japan	Ferring Investigational Site	Kawasaki-shi	Kanagawa
Japan	Ferring Investigational Site	Matsumoto-shi	Nagano
Japan	Ferring Investigational Site	Matsuyama-Shi	Ehime
Japan	Ferring Investigational Site	Minato-ku	Tokyo
Japan	Ferring Investigational Site	Mitaka-shi	Tokyo
Japan	Ferring Investigational Site	Nagakute-shi	Aichi
Japan	Ferring Investigational Site	Nagoya-shi	Aichi
Japan	Ferring Investigational Site	Nankoku-shi	Kochi
Japan	Ferring Investigational Site	Narita-shi	Chiba
Japan	Ferring Investigational Site	Okayama-shi	Okayama
Japan	Ferring Investigational Site	Sapporo-shi	Hokkaido
Japan	Ferring Investigational Site	Sendai-shi	Miyagi
Japan	Ferring Investigational Site	Takatsuki-shi	Osaka
Japan	Ferring Investigational Site	Toyama-shi	Toyama
Japan	Ferring Investigational Site	Tsu-shi	Mie
Japan	Ferring Investigational Site	Tsukuba-shi	Ibaraki
Japan	Ferring Investigational Site	Wakayama-shi	Wakayama
Japan	Ferring Investigational Site	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Incidence of cystectomy		Up to 4 years
Secondary	Time to cystectomy		Up to 4 years
Secondary	Overall survival		Up to 5 years
Secondary	Concentration of FE 999326-specific DNA levels in urine		Up to day 1 of month 4 after start of treatment; and 3, 6, 9 and 12 months after last dose (up to 5 years after start of treatment)
Secondary	Type, incidence, relatedness and severity of treatment emergent adverse events		Up to 5 years