Spots Global Cancer Trial Database for A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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Trial Identification
Brief Title: A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Official Title: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC
Study ID: NCT05375903
Study Description
Brief Summary: This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.
Detailed Description: This master protocol will comprise multiple treatment arms designed to independently investigate intravesical delivery of UGN-301 either as monotherapy or in combination with other agents. Initial study treatment arms will include: * UGN-301 monotherapy * UGN-301 + UGN-201 (imiquimod) in combination * UGN-301 + gemcitabine in combination Additional study treatment arms investigating UGN-301 in combination with other agents may be added in the future. The study will evaluate escalating doses of UGN-301 to determine the biologically effective dose (BED) and maximum tolerated dose (MTD) of UGN-301 either as monotherapy or in combination with other agents. When evaluated in combination with other agents, the UGN-301 dose will begin at least 1 dose level lower than the highest dose level cleared in the monotherapy arm, or 1 dose level lower than the RP2D. Eligible patients in each study treatment arm will enter a 12-week Induction Period. Patients with noninvasive papillary carcinoma and/or tumor that invades the lamina propria (Ta and/or T1) who do not have disease recurrence and patients with carcinoma in situ (CIS) who have a complete response (CR) at 3 months after the start of treatment will return to the clinic for a Safety Follow-up Visit at 6 months after the start of treatment. Ta/T1 patients without disease recurrence and CIS patients with CR at 6 months may enter an Optional Maintenance Period of up to 9 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Urology, Little Rock, Arkansas, United States
UCLA - University of California, Los Angeles, California, United States
Florida Urology Partners, LLC, Tampa, Florida, United States
Johns Hopkins University, Baltimore, Maryland, United States
Manhattan Medical Research, New York, New York, United States
Clinical Research Solutions, Middleburg Heights, Ohio, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
I.R.C.C.S. Ospedale San Raffaele, Milan, , Italy
National Tumor Institute Fondazione G. Pascale, Naples, , Italy
Istituto Oncologico Veneto, Padova, , Italy
NEXT Oncology IOB- Hospital Quironsalud Barcelona, Barcelona, , Spain
Hospital Clinic de Barcelona Instituto Clinic de Nefrologia y Urologia (ICNU), Barcelona, , Spain
NEXT Oncology- Hospital Quironsalud Mardrid, Madrid, , Spain
Contact Details
Name: Sunil Raju, MBBS
Affiliation: UroGen Pharma
Role: STUDY_DIRECTOR
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