A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Active:	Yes
Cancer Type:	Esophogeal Cancer Lung Cancer Ovarian Cancer Prostate Cancer	NCT ID:	NCT06465069
Trial Phases:	Phase I	Protocol IDs:	18882 (primary) NCI-2024-07005 2024-512927-36-00 J5I-OX-JZYA LOXO-LNC-24001
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Eli Lilly and Company
NCI Full Details:	http://clinicaltrials.gov/show/NCT06465069

Summary

The purpose of this study is to find out whether the study drug, LY4052031, is safe,
tolerable and effective in participants with advanced, or metastatic solid tumors
including urothelial cancer. The study is conducted in two parts - phase Ia
(dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last
up to approximately 4 years.

Objectives

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or
metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an
antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain
cancer cells, delivering the drug to the cancer. This study is comprised of two phases:
Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess
the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended
phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031
at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment
history.

Treatment Sites in Georgia

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

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