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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06465069

Registry updated: 2026-10-22
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Description

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.

Interventions

  • LY4052031 (Drug)
    Intravenous
  • Pembrolizumab (Drug)
    Intravenous

Eligibility criteria

Inclusion 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 Exclusion 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

Conditions

Metastatic Solid Tumor Recurrent Solid Tumor Advanced Solid Tumor Urinary Bladder Neoplasm Triple Negative Breast Cancer Non-small Cell Lung Cancer Esophageal Cancer Pancreatic Cancer Ovarian Cancer Cervical Cancer Head and Neck Squamous Cell Carcinoma Prostate Cancer Renal Pelvis Cancer Bladder Cancer

Locations

  • City of Hope National Medical Center — Duarte, California, United States
  • University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States
  • UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California, United States
  • Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States
  • Florida Cancer Specialists and Research Institute — St. Petersburg, Florida, United States
  • Emory University — Atlanta, Georgia, United States
  • University of Chicago Hospital — Chicago, Illinois, United States
  • IU Simon Cancer Center — Indianapolis, Indiana, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • START Midwest Cancer and Hematology Centers of W Michigan — Grand Rapids, Michigan, United States
  • Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Columbia University Irving Medical Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Sarah Cannon Research Institute — Nashville, Tennessee, United States
  • Tennessee Oncology PLLC — Nashville, Tennessee, United States
  • University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
  • University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States
  • START Mountain Region — West Valley City, Utah, United States
  • St Vincent's Hospital — Darlinghurst, Australia
  • Linear Clinical Research — Nedlands, Australia
  • Beijing Cancer hospital — Beijing, China
  • Sun Yat-sen University Cancer Center — Guangzhou, China
  • Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China
  • Institut Gustave Roussy (Igr) — Villejuif, France
  • National Cancer Center Hospital — Chūōku, Japan
  • National Cancer Center Hospital East — Kashiwa, Chiba, Japan
  • The Cancer Institute Hospital of JFCR — Kōtō City, Japan
  • Aichi Cancer Center Hospital — Nagoya, Japan
  • Asan Medical Center — Seoul, South Korea
  • Catalan Institute of Oncology Duran i Reynals Hospital — Barcelona, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Madrid Norte Sanchinarro — Madrid, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
  • St Bartholomew's Hospital — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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