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Active, not recruiting

NCT Number: NCT05704244

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ferring Investigational Site, Nagakute-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

Other names: nadofaragene firadenovec

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

    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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Incidence of cystectomy

    Time frame: Up to 4 years

  5. Time to cystectomy

    Time frame: Up to 4 years

  6. Overall survival

    Time frame: Up to 5 years

  7. 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)

  8. Type, incidence, relatedness and severity of treatment emergent adverse events

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jan 30, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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