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Clinical Trials in the USA / NCT07827612
Starting soon Phase 2

A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer

NCT07827612 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-12
Last updated
2026-10-08

Condition(s) studied

Urinary Bladder NeoplasmsUrologic NeoplasmsReceptor, Fibroblast Growth Factor, Type 3

Investigational drug(s) / intervention(s)

Vepugratinib →

Vepugratinib: Administered orally

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants with LG IR NMIBC with Complete Response — Baseline, 2 Years
    Complete response rate is defined as negative cystoscopy and negative cytology .
  • Number of Participants with LG UTUC with Complete Response — Baseline, 2 Years
    Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.

Trial sites (1)

FacilityCityRegionStatus
Carolina Urologic Research Center Myrtle Beach South Carolina

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Other trials for the same condition

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations Active, not recruiting
Savolitinib vs. Sunitinib in MET-driven PRCC. Active, not recruiting
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3 Recruiting
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07827612 on ClinicalTrials.gov ↗ ← All trials in the USA