RECRUITING

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

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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 CancerBladder NeoplasmBladder Urothelial CarcinomaUrinary Bladder CancerUrinary Tract CancerUrothelial NeoplasmsUreter CancerNectin-4Antibody Drug Conjugate (ADC)Triple Negative Breast Cancer (TNBC)Non-small Cell Lung Cancer (NSCLC)Head and Neck Squamous Cell Carcinoma (HNSCC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-07-01
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06465069

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have one of the following solid tumor cancers:
  2. * 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
  3. * Cohort A2/B1/B2: urothelial carcinoma
  4. * 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
  5. * Prior Systemic Therapy Criteria:
  6. * 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
  7. * 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.
  8. * Prior enfortumab vedotin specific requirements:
  9. * Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required
  10. * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  11. * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  12. * Measurability of disease
  13. * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  14. * 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
  15. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  16. * Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations
  1. * Individual with known or suspected uncontrolled CNS metastases
  2. * Individual with uncontrolled hypercalcemia
  3. * Individual with uncontrolled diabetes
  4. * Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
  5. * Any serious unresolved toxicities from prior therapy
  6. * Significant cardiovascular disease
  7. * Recent thromboembolic event and/or clinically significant bleeding disorder
  8. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  9. * History of pneumonitis/interstitial lung disease
  10. * History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  11. * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
13176154559
clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
United States
Florida Cancer Specialists and Research Institute
St Petersburg, Florida, 33705
United States
Massachusetts General Hospital
Boston, Massachusetts, 02215
United States
START Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids, Michigan, 49546
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
United States
Columbia University Irving Medical Center
New York, New York, 10032-3729
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
START Mountain Region
West Valley, Utah, 84119
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2027-05

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

  • 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