A Phase 3 Single-arm Study of UGN-103 for the Treatment of LG IR NMIBC.
- Conditions
- onmuscle Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507261-25-00
- Lead Sponsor
- rogen Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 67
1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., 2. Patient must be = 18 years of age at the time of informed consent., 3. Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening. Note: This is a diagnostic biopsy to demonstrate histopathology of tumor and resection of the tumor is not to be performed. Residual tumor must be present and documented after biopsy and before instillation of study treatment., 4. 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., 5. Has intermediate risk disease, defined as having 1 or 2 of the following: a. Presence of multiple tumors. b. Solitary tumor > 3 cm. c. Early or frequent recurrence (= 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit) Note: Patients with all 3 factors are considered high risk and are not eligible to participate., 6. Negative voiding cytology for HG disease within 8 weeks before Screening, 7. Has adequate organ and bone marrow function as determined by routine laboratory tests as below: • Leukocytes = 3,000/µL (= 3 × 109/L). • Absolute neutrophil count = 1,500/µL (= 1.5 × 109/L). • Platelets = 100,000/µL (= 100 × 109/L). • Hemoglobin = 9.0 g/dL. • Total bilirubin = 1.5 × ULN. • AST and ALT = 2.5 × ULN. • ALP = 2.5 × ULN. • eGFR = 30 mL/min., 8. Has an anticipated life expectancy of at least the duration of the trial., 9. Both male and female patients: Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Female partner of male patient: Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the female partner is of childbearing potential (defined as premenopausal women who have not been sterilized). Acceptable methods of birth control which are considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (only hormonal), condoms with spermicide, sexual abstinence* or vasectomized partner. * Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, postovulation methods) is NOT an acceptable method of contraception. b. Female patient: Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the patient is of childbearing potential (defined as premenopausal women who have not been sterilized)
1. Received BCG treatment for UC within the previous 1 year., 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 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, 2. History of HG bladder cancer (papillary or CIS) 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: a. Neurogenic bladder. b. Active urinary retention. c. 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 staging of T1, 8. Concurrent UTUC, 9. Evidence of active UTI that in the investigator’s opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method