Trial Identifiers
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Scientific Title
A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
Commercial Sponsor
CG Oncology, Inc.
Summary
This is a single arm study for people with non-muscular invasive bladder cancer with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease, who have been unresponsive to prior BCG therapy.
All participants will receive the same treatment. CG0070 will be administered intravesically (via urethral catheter) following a sequence of bladder washes with 5% DDM (n-dodecyl-B-D-maltoside Transduction-enhancing agent) and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the participant has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response), then the participant will receive 3 weekly treatments. Beginning at Week 25, participants will receive weekly x3 treatments every 12 weeks through week 49, then every 24 weeks thereafter.