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Taking people in United StatesPhase 1

Tests LY4052031 in adults with advanced solid tumors, including urothelial cancer

Tests the drug LY4052031 in adults with advanced or spreading solid tumors, including urothelial cancer.

Key facts

Who runs it
Eli Lilly and Company
Where
Atlanta, Boston, Chicago, Cleveland, Denver, Duarte, Grand Rapids, Houston, Indianapolis, La Jolla, Los Angeles, Nashville, New York, Salt Lake City, San Antonio, St Louis, St. Petersburg, and West Valley City, United StatesSee the 22 sitesAlso in 7 other countries, 17 sites
Registry title
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
460 people, planned
Started
1 Jul 2024
Expected to end
May 2027
Type of study
Interventional, 4 groups
Treatments tested
  • LY4052031
  • Pembrolizumab
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic urothelial cancer or certain other solid tumors, to test the study drug LY4052031.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Advanced or metastatic urothelial carcinoma, or other solid tumors (triple negative breast, non-small cell lung, esophageal, pancreatic, ovarian, cervical, head and neck squamous cell, or prostate cancer, depending on the cohort). Measurable disease is required in all cohorts; cohort A1 may also accept non-measurable disease.
Earlier treatment
Depends on the cohort. Some need all standard therapies already received, or none available. Some need at least one earlier treatment for advanced or metastatic disease. One cohort is for people with no earlier treatment for locally advanced or metastatic urothelial cancer. Earlier enfortumab vedotin is allowed in some cohorts, required in one and not allowed in another.

Main reasons for not taking part

  • Uncontrolled spread of cancer to the brain or spinal cord (CNS metastases)
  • Uncontrolled high calcium level or uncontrolled diabetes
  • Corneal keratopathy or keratitis, or a past corneal transplant
  • History of pneumonitis or interstitial lung disease
  • Pregnant or breastfeeding, or planning to breastfeed during the study or within 30 days of the last dose

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

Also in 7 other countries, 17 sites

  • Emory UniversityAtlanta, United StatesTaking people
  • Massachusetts General HospitalBoston, United StatesTaking people
  • University of Chicago HospitalChicago, United StatesTaking people
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
  • Sarah Cannon Research Institute at HealthONEDenver, United StatesTaking people
  • City of Hope National Medical CenterDuarte, United StatesTaking people
  • START Midwest Cancer and Hematology Centers of W MichiganGrand Rapids, United StatesTaking people
  • University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
  • IU Simon Cancer CenterIndianapolis, United StatesNot yet recruiting
  • University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesTaking people
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesTaking people
  • Sarah Cannon Research InstituteNashville, United StatesTaking people
  • Tennessee Oncology, PLLCNashville, United StatesNot yet recruiting
  • Columbia University Irving Medical CenterNew York, United StatesTaking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)New York, United StatesTaking people
  • University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
  • South Texas Accelerated Research Therapeutics (START)San Antonio, United StatesTaking people
  • Washington University School of Medicine in St. LouisSt Louis, United StatesTaking people
  • Florida Cancer Specialists and Research InstituteSt. Petersburg, United StatesNo longer taking part
  • START Mountain RegionWest Valley City, United StatesTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • LY4052031 (Dose-escalation, Cohort A1)Treatment being tested

    Escalating doses of LY4052031 administered intravenously (IV).

    Treatment: LY4052031

  • LY4052031 (Dose-optimization, Cohort A2)Treatment being tested

    Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.

    Treatment: LY4052031

  • LY4052031 (Dose-expansion, Cohort B1, B2, C1)Treatment being tested

    LY4052031 administered IV.

    Treatment: LY4052031

  • LY4052031+ Pembrolizumab (Dose-expansion, Cohort D)Treatment being tested

    LY4052031 administered IV. Pembrolizumab administered IV.

    Treatment: LY4052031 and Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests LY4052031 in adults with advanced solid tumors, including urothelial cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026