NCT07827612

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for phase_2

Timeline
52mo left

Started Dec 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

September 18, 2026

Status Verified

August 1, 2026

Enrollment Period

1.6 years

First QC Date

September 15, 2026

Last Update Submit

September 15, 2026

Conditions

Urinary Bladder NeoplasmsUrologic NeoplasmsReceptor, Fibroblast Growth Factor, Type 3

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with LG IR NMIBC with Complete Response

    Complete response rate is defined as negative cystoscopy and negative cytology .

    Baseline, 2 Years

  • Number of Participants with LG UTUC with Complete Response

    Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.

    Baseline, 2 Years

Secondary Outcomes (2)

  • Duration of Response

    Baseline, 5 Years

  • Time to Recurrence

    Baseline, 5 Years

Study Arms (2)

Cohort A: Vepugratinib

EXPERIMENTAL

Vepugratinib will be administered orally to participants with low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC)

Drug: Vepugratinib

Cohort B: Vepugratinib

EXPERIMENTAL

Vepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC)

Drug: Vepugratinib

Interventions

VepugratinibDRUG

Administered orally

Also known as: LY3866288
Cohort A: VepugratinibCohort B: Vepugratinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 18, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

March 1, 2031

Last Updated

September 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations

US(1)