SUSPENDED

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

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.

Conditions

Metastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerNon-small Cell Lung CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerHead and Neck Squamous Cell CarcinomaProstate CancerRenal Pelvis CancerBladder Cancer
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Related Conditions:

Metastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerNon-small Cell Lung CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerHead and Neck Squamous Cell CarcinomaProstate CancerRenal Pelvis CancerBladder Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Metastatic Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States, 80218

Saint Petersburg

Florida Cancer Specialists and Research Institute, Saint Petersburg, Florida, United States, 33705

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02215

Grand Rapids

START Midwest Cancer and Hematology Centers of W Michigan, Grand Rapids, Michigan, United States, 49546

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029-6574

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032-3729

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030-4000

San Antonio

South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Cohorts A2, B1, B2, C: measurable disease required 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
  • * 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 or 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-05