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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY4052031 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?39 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: LY4052031; Drug: Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Have one of the following solid tumor cancers:
Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
Cohort A2/B/D: urothelial carcinoma
Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer
Prior Systemic Therapy Criteria:
Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer.
Prior enfortumab vedotin specific requirements:
Cohorts A1/A2/C/D: prior treatment with enfortumab vedotin is allowed, but not required
Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
Measurability of disease
Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Reasons someone may not be able to joinExclusion criteria

Individual with known or suspected uncontrolled CNS metastases
Individual with uncontrolled hypercalcemia
Individual with uncontrolled diabetes
Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Recent thromboembolic event and/or clinically significant bleeding disorder
Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
History of pneumonitis/interstitial lung disease
History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation
Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of Hope National Medical CenterDuarte, California
University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, California
UCLA Department of Medicine-Hematology/OncologyLos Angeles, California
Sarah Cannon Research Institute at HealthOneDenver, Colorado
Florida Cancer Specialists and Research InstituteSt. Petersburg, Florida
Emory UniversityAtlanta, Georgia
University of Chicago HospitalChicago, Illinois
IU Simon Cancer CenterIndianapolis, Indiana
Massachusetts General HospitalBoston, Massachusetts
START Midwest Cancer and Hematology Centers of W MichiganGrand Rapids, Michigan
Washington University School of Medicine in St. LouisSt Louis, Missouri
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)New York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 22, 2026. Always confirm current availability with the study team.

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