← Back to all trials
Not Yet Recruiting
NCT07827612
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
Conditions: Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 161
Sponsor: Eli Lilly and Company
Location: Carolina Urologic Research Center, LLC Myrtle Beach South Carolina
Summary
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.
For each participant, the study will last up to 5 years.
Eligibility Criteria
Inclusion Criteria:
* All Participants:
* Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale
* Cohort A
* Have histologically confirmed LG NMIBC.
* Have LG IR NMIBC at time of screening
* Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion
* Cohort B
* Have histologically confirmed LG UTUC.
Exclusion Criteria:
* All Participants
* Have had a prior positive urine cytology within 6 weeks of first day of treatment.
* Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment.
* Cohort A
* Have synchronous UTUC disease.
* Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ.
* Cohort B
* Have presence of bladder tumors at the time of enrollment.
* Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.
Source: ClinicalTrials.gov (NCT07827612). StuddyBuddy aggregates publicly available trial information.