FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

Active:	Yes
Cancer Type:	Bladder Cancer Solid Tumor Unknown Primary	NCT ID:	NCT05614739
Trial Phases:	Phase I	Protocol IDs:	LOXO-FG3-22001 (primary) NCI-2023-00367 022-502755-59-00 2022-502755-59-00 J4G-OX-JZVA
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Eli Lilly and Company
NCI Full Details:	http://clinicaltrials.gov/show/NCT05614739

Summary

The main purpose of this study is to learn more about the safety, side effects, and
effectiveness of Vepugratinib by itself or when it is combined with other medicines that
treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary
system and other solid tumor cancers that have a change in a particular gene (known as
the FGFR3 gene). Study participation could last up to approximately 6 years, depending on
which part of the study you join.

Objectives

This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered
advanced solid tumor malignancy including metastatic urothelial cancer (UC),
muscle-invasive bladder cancer (MIBC), and low grade intermediate risk
non-muscle-invasive bladder cancer (LG IR NMIBC). The study will be conducted in 2
phases. Phase 1a will assess safety, tolerability, and pharmacokinetics of Vepugratinib
to determine the optimal dose for further expansion. Phase 1b will include dose expansion
cohorts to evaluate the efficacy and safety of Vepugratinib as monotherapy or in
combinations with other medicines that treat cancer.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.