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

A Phase 3 study testing FE 999326 in people with Bladder Cancer, run by Ferring Pharmaceuticals at 24 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

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

Who is it for?: Ages 20 years and older
Conditions the study is for: Bladder Cancer
What is being tested?: FE 999326
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 24 sitesJapan
Study dates: 21 Dec 2022to 30 Nov 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Japan24 sites

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

Other trials in Japan

About this study

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)

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

Conditions: Bladder Cancer
Being tested: FE 999326
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FE 999326Drug
Also called nadofaragene firadenovec
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

Study groups in NCT05704244
Study group	Role	What they receive
FE 999326	Experimental	Not described Receives: Drug: FE 999326

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to 5 years
Incidence of cystectomy
Measured: Up to 4 years
Time to cystectomy
Measured: Up to 4 years
Overall survival
Measured: Up to 5 years
Concentration of FE 999326-specific DNA levels in urine
Measured: 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)
Type, incidence, relatedness and severity of treatment emergent adverse events
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 202230 Nov 2029

First posted30 Jan 2023
Study start21 Dec 2022
Primary completion30 Nov 2029 (estimated)
Study completion30 Nov 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05704244
Sponsor's protocol ID: 000381
Status last verified: Sep 2026
First submitted: 21 Dec 2022
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05704244
Acronym / sponsor ID: 000381
Conditions: Bladder Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 25 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 21 Dec 2022 (actual)
Primary completion: 30 Nov 2029 (estimated)
Study completion: 30 Nov 2029 (estimated)
First posted: 30 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FE 999326	Experimental	Drug: FE 999326

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Have at entry, confirmed by a pathology report:
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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FE 999326Also: nadofaragene firadenovec75 mL FE 999326 (3 x 10^11 vp/mL) of sterile suspension instilled once every 3 months into the bladder via a urinary catheter	Drug	FE 999326

Primary outcome

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
Time frame: At Month 12 assessment
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.

8 secondary outcomes

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
Time frame: 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
Time frame: 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)
Time frame: Up to 5 years
Incidence of cystectomy
Time frame: Up to 4 years
Time to cystectomy
Time frame: Up to 4 years
Overall survival
Time frame: Up to 5 years
Concentration of FE 999326-specific DNA levels in urine
Time frame: 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)
Type, incidence, relatedness and severity of treatment emergent adverse events
Time frame: Up to 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Compliance study director

Ferring Pharmaceuticals

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FE 999326 in people with Bladder Cancer, run by Ferring Pharmaceuticals at 24 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At Month 12 assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05704244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.