A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Inclusion Criteria:

1. Capable of giving written informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form and the protocol.

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

3. History of LG-NMIBC requiring treatment with transurethral resection of bladdertumors (TURBT). Note: This refers to a previous episode(s) and not to the currentepisode for which the patient is being screened.

4. 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 thecurrent diagnosis at the initial Screening Visit).

5. Negative voiding cytology for high-grade (HG) disease within 8 weeks beforeScreening.

6. Has adequate organ and bone marrow function as determined by routine laboratorytests 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 and alanine aminotransferase ≤ 2.5 × ULN;

• Alkaline phosphatase ≤ 2.5 × ULN;

• Estimated glomerular filtration rate ≥ 30 mL/min.

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

8. Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.Women of childbearing potential (defined as premenopausal women who have not beensterilized), including female patients and female partners of male patients, must bewilling to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Exclusion Criteria:

1. Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) withinprevious 1 year.

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

3. Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannotbe readily managed.

4. Clinically significant urethral stricture that would preclude passage of a urethralcatheter.

5. History of:

• Neurogenic bladder;

• Active urinary retention;

• Any other condition that would prohibit normal voiding.

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

7. Current tumor grading of T1.

8. Concurrent upper tract UC.

9. Evidence of active urinary tract infection that in the Investigator's opinion cannotbe treated and resolved prior to biopsy and/or administration of study treatment.

10. Is pregnant or breastfeeding.

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

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

13. Has participated in a study with an investigational agent or device within 30 daysof enrollment.

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

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

16. Has any other clinically significant medical or surgical condition that in theInvestigator's opinion could compromise patient safety or the interpretation ofstudy results.