A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
BL013 (primary)
NCI-2025-00695
Summary
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of
UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients
with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
Objectives
Eligible patients will be treated with UGN-103 once weekly for 6 weeks (a total of 6
doses).
Efficacy will be assessed by the complete response rate (CRR) at the 3-month Visit
(approximately 3 months after the first instillation). Response will be determined based
on visual observation (white light cystoscopy), histopathology of any remaining or new
lesions by central pathology lab (if applicable), and interpretation of urine cytology by
central pathology lab.
Patients who have a complete response (CR) at the 3-month Visit, defined as having no
detectable disease (NDD) in the bladder, will enter the Follow-up Period of the study.
During the Follow-up Period, patients will return to the clinic every 3 months for
evaluation of response. Patients will remain on study until disease recurrence, disease
progression, death, or the last patient completes 12 months of follow-up (ie, 15 months
after the first instillation), whichever occurs first.
Patients who have a non-complete response (NCR) at the 3-month Visit will undergo
investigator designated standard of care (SOC) and have a separate End of Study (EOS)
Visit performed.
Eligibility
- Provide 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 at least 1 prior episode of NMIBC. 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:
- Leukocytes = 3,000/µL.
- Absolute neutrophil count = 1,500/µL.
- Platelets = 100,000/µL.
- Hemoglobin = 9.0 g/dL.
- Total bilirubin = 1.5 × 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.
Treatment Sites in Georgia
5077 Dallas Highway
Suite 315
Powder Springs, GA 30127
(404) 905-7098
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