Recruiting
Phase 1

LY4052031

Sponsor:

Eli Lilly and Company

Code:

NCT06465069

Conditions

Metastatic Solid Tumor

Recurrent Solid Tumor

Advanced Solid Tumor

Urinary Bladder Neoplasm

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY4052031

Study Details

Brief 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.

Conditions

Metastatic Solid Tumor

Recurrent Solid Tumor

Advanced Solid Tumor

Urinary Bladder Neoplasm

Triple Negative Breast Cancer

Study ID

NCT06465069

Start date

Jul 1, 2024

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4052031 (Dose-escalation, Cohort A1)

Escalating doses of LY4052031 administered intravenously (IV).

experimental: LY4052031 (Dose-optimization, Cohort A2)

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

experimental: LY4052031 (Dose-expansion, Cohort B1, B2, C1)

LY4052031 administered IV.

Interventions

LY4052031

Intravenous

Primary outcome measure

  • Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 [ Time Frame: Cycle 1 (21 Days) ]
  • Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR) [ Time Frame: Up to Approximately 48 Months or 4 Years ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-0269

UCLA Department of Medicine-Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90024

Sarah Cannon Research Institute at HealthOne

Recruiting

Denver, Colorado, United States, 80218

University of Chicago Hospital

Recruiting

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02215

START Midwest Cancer and Hematology Centers of W Michigan

Recruiting

Grand Rapids, Michigan, United States, 49546

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029-6574

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032-3729

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4000

South Texas Accelerated Research Therapeutics (START)

Recruiting

San Antonio, Texas, United States, 78229

University of Utah - Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Bladder Cancer
  • Bladder Neoplasm
  • Bladder Urothelial Carcinoma
  • Urinary Bladder Cancer
  • Urinary Tract Cancer
  • Urothelial Neoplasms
  • Renal Pelvis Cancer
  • Ureter Cancer
  • Nectin-4
  • Antibody Drug Conjugate (ADC)
  • Triple Negative Breast Cancer (TNBC)
  • Non-small Cell Lung Cancer (NSCLC)
  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.