ClinicalTrials.gg
Not yet recruitingNCT07827612FORAYUpdated Oct 8, 2026

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

A Phase 2 interventional study of Vepugratinib in Urinary Bladder Neoplasms, Urologic Neoplasms and Receptor, Fibroblast Growth Factor, Type 3, sponsored by Eli Lilly and Company. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Updated Oct 8, 20261 site added1 site removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
161
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Receptor, Fibroblast Growth Factor, Type 3
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's planned enrollment of 161 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All Participants:

    • Have a PS of 0 to 2 on the Performance Status (ECOG PS) scale
  • Cohort A

    • Have 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
161 participants (estimated)

Study arms

  • Experimental
    Cohort A: Vepugratinib

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

    Drug: Vepugratinib

  • Experimental
    Cohort B: Vepugratinib

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

    Drug: Vepugratinib

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants with LG IR NMIBC with Complete Response

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

    Time frame: Baseline, 2 Years

  2. 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.

    Time frame: Baseline, 2 Years

Secondary outcomes

  1. Duration of Response

    Time frame: Baseline, 5 Years

  2. Time to Recurrence

    Time frame: Baseline, 5 Years

07

Study locations

1 site
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina 29572, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Carolina Urologic Research Center · Myrtle Beach, United States
Show 1 removed
  • Carolina Urologic Research Center, LLC · Myrtle Beach, United States
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    1 site added, 1 site removed
    Show site
    • Carolina Urologic Research Center · Myrtle Beach, United States
    Show 1 removed
    • Carolina Urologic Research Center, LLC · Myrtle Beach, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07827612
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Mar 2031 (estimated)
Last update
Oct 8, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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