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NCT Number: NCT07827612

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

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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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Receptor, Fibroblast Growth Factor, Type 3 Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vepugratinib

Drug

Administered orally

Other names: LY3866288

Primary outcomes

  1. 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 .

  2. 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.

Secondary outcomes

  1. Duration of Response

    Time frame: Baseline, 5 Years

  2. Time to Recurrence

    Time frame: Baseline, 5 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: FORAY

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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