Urinary Bladder NeoplasmsPhase 2FORAYNCT07827612
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
A Phase 2 study testing Vepugratinib in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
- What is being tested?
- Vepugratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
About this study
Official title: FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma
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.
- Being tested
- Vepugratinib
- Medical subject headings
- Urinary Bladder Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VepugratinibDrug
Also called LY3866288
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Vepugratinib | Experimental | Vepugratinib will be administered orally to participants with low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC) Receives: Drug: Vepugratinib |
| Cohort B: Vepugratinib | Experimental | Vepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC) Receives: Drug: Vepugratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with LG IR NMIBC with Complete Response
Complete response rate is defined as negative cystoscopy and negative cytology .
Measured: 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.
Measured: Baseline, 2 Years
Secondary outcomes (2)
Duration of Response
Measured: Baseline, 5 Years
Time to Recurrence
Measured: Baseline, 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827612
- Sponsor's protocol ID
- 27984
- Other IDs
- J4G-MC-JZVH
- Acronym
- FORAY
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07827612
- Acronym / sponsor ID
- FORAY / 27984
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Vepugratinib | Experimental | Drug: VepugratinibVepugratinib will be administered orally to participants with low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC) |
| Cohort B: Vepugratinib | Experimental | Drug: VepugratinibVepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All Participants:
- Cohort A
- Cohort B
Key exclusion criteria (9 listed)
- All Participants
- Cohort A
- Cohort B
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VepugratinibAlso: LY3866288Administered orally | Drug | Cohort A: Vepugratinib, Cohort B: Vepugratinib |
Primary outcome
Number of Participants with LG IR NMIBC with Complete Response
Time frame: Baseline, 2 Years
Complete response rate is defined as negative cystoscopy and negative cytology .
Number of Participants with LG UTUC with Complete Response
Time frame: Baseline, 2 Years
Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.
2 secondary outcomes
Duration of Response
Time frame: Baseline, 5 Years
Time to Recurrence
Time frame: Baseline, 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vepugratinib in people with Urinary Bladder Neoplasms and Urologic Neoplasms, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with LG IR NMIBC with Complete Response (time frame: Baseline, 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.