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

RecruitingPhase 1

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Who can join

Ages 18 and older · All sexes

Full 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/B1/B2: 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.
* Prior enfortumab vedotin specific requirements:

  * Cohorts A1/A2/C: 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 when receiving enfortumab vedotin
* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 420 · Started: Jul 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06465069

Locations in the U.S.

CaliforniaCity of Hope National Medical Center, Duarte
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla (Not yet recruiting)
UCLA Department of Medicine-Hematology/Oncology, Los Angeles
ColoradoSarah Cannon Research Institute at HealthOne, Denver
IllinoisUniversity of Chicago Hospital, Chicago
IndianaIU Simon Cancer Center, Indianapolis (Not yet recruiting)
MassachusettsMassachusetts General Hospital, Boston
MichiganSTART Midwest Cancer and Hematology Centers of W Michigan, Grand Rapids
MissouriWashington University School of Medicine in St. Louis, St Louis
New YorkColumbia University Irving Medical Center, New York
Icahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute), New York
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute), New York (Not yet recruiting)
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
TennesseeSarah Cannon Research Institute, Nashville
Tennessee Oncology PLLC, Nashville (Not yet recruiting)
TexasUniversity of Texas MD Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics (START), San Antonio
UtahUniversity of Utah - Huntsman Cancer Institute, Salt Lake City
START Mountain Region, West Valley City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.