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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT06465069
Run by: Eli Lilly and Company
People needed: 420
Starts: 2024-07-01
Expected to finish: 2027-05-01
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
Hospital Madrid Norte Sanchinarro — Madrid, Spain (enrolling)
Hospital Universitario Virgen Del Rocio — Seville, Spain (enrolling)
St Bartholomew's Hospital — London, United Kingdom (enrolling)
City of Hope National Medical Center — Duarte, California, United States (enrolling)
UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California, United States (enrolling)
Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States (enrolling)
University of Chicago Hospital — Chicago, Illinois, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
START Midwest Cancer and Hematology Centers of W Michigan — Grand Rapids, Michigan, United States (enrolling)
Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (enrolling)
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute) — New York, New York, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Columbia University Irving Medical Center — New York, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States (enrolling)
University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
START Mountain Region — West Valley City, Utah, United States (enrolling)
St Vincent's Hospital — Darlinghurst, Australia (enrolling)
Linear Clinical Research — Nedlands, Australia (enrolling)
Beijing Cancer hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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