A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

Launched by UROGEN PHARMA LTD. · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called UGN-103 for patients with low-grade non-muscle invasive bladder cancer. The goal is to see how effective and safe this treatment is when it is placed directly into the bladder. The trial is currently looking for participants aged between 65 and 74 who have been diagnosed with this type of bladder cancer and have had at least one prior episode. To be eligible, participants must have specific health conditions that allow them to safely receive the treatment and must not have had certain other treatments or health issues that could complicate the trial.

If you or a loved one qualifies for this study, you can expect to receive the UGN-103 treatment and be monitored closely by healthcare professionals throughout the trial. Participants will need to follow some guidelines, such as using contraception if they are capable of becoming pregnant. This trial provides an opportunity to contribute to important research that could help improve treatment options for bladder cancer in the future.

Gender

ALL

Eligibility criteria

• 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-Guérin (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.