Brief Title: UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate (CRR)

Primary Outcome 1 - Timeframe: 3 months

CONDITION

• Bladder Cancer
• Urothelial Carcinoma
• Urothelial Carcinoma Bladder

ELIGIBILITY

Inclusion Criteria:
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.

- Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.

- History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
Has intermediate risk disease, defined as having 1 or 2 of the following:
Presence of multiple tumors;

- Solitary tumor > 3 cm;

- Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).

- Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening.
Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
Leukocytes ≥ 3,000 per μL;

- Absolute neutrophil count ≥ 1,500 per μL;

- Platelets ≥ 100,000 per μL;

- Hemoglobin ≥ 9.0 g/dL;

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;

- Alkaline phosphatase (ALP) ≤ 2.5 × ULN;

- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

- Has an anticipated life expectancy of at least the duration of the trial.

- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.
Exclusion Criteria:
Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.

- History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years.

- Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed.

- Clinically significant urethral stricture that would preclude passage of a urethral catheter.
History of:
Neurogenic bladder;

- Active urinary retention;

- Any other condition that would prohibit normal voiding.

- Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.

- Current tumor grading of T1.

- Concurrent upper tract urothelial carcinoma (UTUC).

- Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.

- Is pregnant or breastfeeding.

- Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol.

- History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.

- Has participated in a study with an investigational agent or device within 30 days of enrollment.

- Has previously participated in a study in which they received UGN-102.

- Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed.

- Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sandip Prasad, MD

Role: Principal Investigator

Affiliation: Atlantic Health System

Overall Contact

Name: Sandip Prasad, MD

Phone: +1 215-809-9828, +1 646-844-6084

Email: christy.obercian@urogen.com, jessica.walker@urogen.com

LOCATION