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

NCT07827612 — Phase 2, Not yet recruiting, 161 participants, Eli Lilly and Company

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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

Registry	NCT07827612, acronym FORAY
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	161 (Estimated)
Sponsor	Eli Lilly and Company (Industry)
Conditions	Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
Interventions	Vepugratinib (Drug)
Dates	start 2026-12-01 (estimated), primary completion 2028-07-01 (estimated), completion 2031-03-01 (estimated), first posted 2026-09-18, last updated 2026-10-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cohort A: Vepugratinib	Experimental	Drug: Vepugratinib	Vepugratinib will be administered orally to participants with low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC)
Cohort B: Vepugratinib	Experimental	Drug: Vepugratinib	Vepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC)

Vepugratinib (Drug), also known as LY3866288: Administered orally

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Duration of Response [Baseline, 5 Years]
Time to Recurrence [Baseline, 5 Years]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Carolina Urologic Research Center	Myrtle Beach, South Carolina	United States

+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