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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urologic Neoplasms; Urinary Bladder Neoplasms; Receptor, Fibroblast Growth Factor, Type 3
• Intervention / Treatment: Drug: Vepugratinib

• Study Type: Interventional
• Enrollment (Estimated): 161
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Administered orally; Other Names: LY3866288
Experimental: Cohort B: Vepugratinib; Vepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC)	Drug: Vepugratinib; Administered orally; Other Names: LY3866288

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Duration of Response	Baseline, 5 Years
Time to Recurrence	Baseline, 5 Years

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: September 15, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Urologic Neoplasms
• Other Study ID Numbers: 27984; J4G-MC-JZVH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No