A Phase III, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence

Study Identifier:
BL013
CT.gov Identifier:
NCT06331299
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-507261-25-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To 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).

To explore the safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: UGN-103
    • Read More
  • Drug: Intervention/treatment:
  • Drug: During the follow-up period, patients will return to the clinic every three 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 (i.e., 15 months after the first instillation), whichever occurs first.
  • Drug: All enrolled patients receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • 1. Provide written informed consent, which includes compliance with the requirements and
    • restrictions listed in the informed consent form (ICF) and the protocol.
    • 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening
    • or within 8 weeks before Screening.
    • 3. 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.
    • 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 the
    • current diagnosis at the initial Screening Visit).
    • 5. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
    • 6. 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.
    • 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 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
    • 1. Received Bacillus Calmette-Guerin (BCG) treatment for urothelial carcinoma (UC) within
    • the previous 1 year.
    • 2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
    • 3. Known allergy or sensitivity to any component of the study treatment (including
    • excipients) that in the investigator's opinion cannot be readily managed.
    • 4. Clinically significant urethral stricture that would preclude passage of a urethral
    • catheter.
    • 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 stage of T1.
    • 8. Concurrent upper tract urothelial carcinoma (UTUC).
    • 9. 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.
    • 10. Is pregnant or breastfeeding.
    • 11. 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.
    • 12. 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
    • transurethral resection of bladder tumors (TURBT).
    • 13. Has participated in a study with an investigational agent or device within 30 days of
    • 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 as
    • cutaneous basal cell or squamous cell carcinomas that can be treated locally are
    • allowed.
    • 16. 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.
    • 17. Where applicable per country regulation, the patient must not be currently committed
    • to an institution by virtue of an order issued by either judicial or administrative
    • authorities.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Abhishek Srivastava
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Urinary tract