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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-21

Study Completion Date

2029-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

NCT06241755

Non-Muscle Invasive Bladder Cancer

RECRUITING PHASE3

An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

NCT06443944

Non-Muscle Invasive Bladder Cancer Urothelial Carcinoma Urologic Cancer +1 more

AVAILABLE

Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients

NCT06427291

Bladder Cancer

RECRUITING PHASE1

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC

NCT06971614

Nonmuscle-invasive Bladder Cancer

RECRUITING PHASE2

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer

NCT06255964

Bladder Cancer

NOT_YET_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FE 999326

Group Type EXPERIMENTAL

FE 999326

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nadofaragene firadenovec

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No