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Vepugratinib

DRUG4 trials

Sponsors

Eli Lilly and Company

Conditions

Carcinoma, Transitional CellNeoplasm MetastasisReceptor, Fibroblast Growth Factor, Type 3Ureteral NeoplasmsUrinary Bladder NeoplasmsUrologic Neoplasms

Phase 1

FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
RecruitingNCT05614739
Eli Lilly and CompanyNeoplasm Metastasis, Ureteral Neoplasms, Urinary Bladder Neoplasms
Start: 2023-01-12End: 2027-06-01Target: 677Updated: 2026-08-20

Phase 2

A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
Not yet recruitingNCT07827612
Eli Lilly and CompanyReceptor, Fibroblast Growth Factor, Type 3, Urinary Bladder Neoplasms, Urologic Neoplasms
Start: 2026-12-01End: 2031-03-01Target: 161Updated: 2026-10-08

Phase 3

A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
RecruitingNCT07218380
Eli Lilly and CompanyCarcinoma, Transitional Cell, Neoplasm Metastasis, Urinary Bladder Neoplasms
Start: 2025-12-12End: 2033-05-01Target: 450Updated: 2026-10-07

Unknown Phase

Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors
NCT07675057
Eli Lilly and CompanyCarcinoma, Transitional Cell, Neoplasm Metastasis, Urinary Bladder Neoplasms
Updated: 2026-06-30

Related Papers

Abstract A090: Vepugratinib (LY3866288), a potent highly isoform-selective FGFR3 inhibitor, enhances the activity of enfortumab vedotin (EV) in FGFR3-altered metastatic urothelial cancer (mUC) models
Molecular Cancer Therapeutics2025-10-22
A first-in-human phase 1 study of LY3866288 (LOXO-435), a potent, highly isoform-selective FGFR3 inhibitor (FGFR3i) in advanced solid tumors with <i>FGFR3</i> alterations: Initial results from FORAGER-1.
Journal of Clinical Oncology2025-02-1010 citations
A Phase I Study of KIN-3248, an Irreversible Small-molecule Pan-FGFR Inhibitor, in Patients with Advanced FGFR2/3-driven Solid Tumors
Cancer Research Communications2024-04-1116 citations
Development of a novel RNA-based fibroblast growth factor receptor response signature (FGFR-PRS) for use in patients with urothelial cancer (UC).
Journal of Clinical Oncology2024-01-29
Abstract CT119: A first-in-human phase 1 study of LOXO-435, a potent, highly isoform-selective FGFR3 inhibitor in advanced solid tumors with <i>FGFR3</i> alterations (trial in progress)
Cancer Research2023-04-149 citations