A Study of LOXO-435 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. 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 1a/b study in participants with FGFR3-altered
advanced solid tumors, including metastatic urothelial cancer (UC). The study will be
conducted in 2 phases: Dose escalation and dose optimization (1a) and dose expansion
(1b). Phase 1a will include up to 2 cohorts to assess safety, tolerability, and
pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D) (or optimal
dose). Phase 1b will include 4 dose expansion cohorts of participants with prespecified
activating FGFR3 alterations to evaluate the efficacy and safety of LOXO-435 at the RP2D.
Cohort B will enroll pts with metastatic UC and includes three cohorts to evaluate
LOXO-435 as monotherapy (B1, B2) and in combination with pembrolizumab (B3). Cohort C
will enroll pts with non-UC advanced solid tumors and includes a cohort to evaluate
LOXO-435 as monotherapy (C1).

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.