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

Ferring

Status and phase

Active, not recruiting

Phase 3

Conditions

Bladder Cancer

Treatments

Drug: FE 999326

Study type

Interventional

Funder types

Industry

Identifiers

000381

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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