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

Active:	Yes
Cancer Type:	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 LOXO-435 by itself or when it is combined with other standard medicines
that treat cancer. LOXO-435 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). Participation could last up to 30 months (2.5 years) and
possibly longer if the disease does not get worse.

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). The study
will be conducted in 2 phases: Phase 1a dose escalation (Cohort A1) and dose optimization
(Cohort A2) and Phase 1b dose expansion. Phase 1a will assess safety, tolerability, and
pharmacokinetics of LOXO-435 to determine the optimal dose for further expansion.

Phase 1b will include 6 dose expansion cohorts to evaluate the efficacy and safety of
LOXO-435 as monotherapy or in combinations with pembrolizumab with or without enfortumab
vedotin.

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.