RECRUITING

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic 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)

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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, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. 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 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2024-03-05
Study Completion:2027-03-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06238479

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 C1: triple negative breast cancer
  5. * Cohort C2: non-small cell lung cancer
  6. * Cohort C3: ovarian or fallopian tube cancer
  7. * Cohort C4: cervical cancer
  8. * Cohort C5: head and neck squamous cell carcinoma
  9. * Prior Systemic Therapy Criteria:
  10. * Cohort A1/C1-5: 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
  11. * 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.
  12. * Prior enfortumab vedotin specific requirements:
  13. * Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
  14. * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  15. * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  16. * Measurability of disease
  17. * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  18. * Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
  19. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  20. * 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 history of corneal transplant
  5. * Any serious unresolved toxicities from prior therapy
  6. * Significant cardiovascular disease
  7. * Current of history of intestinal obstruction in the previous 3 months
  8. * Recent thromboembolic event or bleeding disorder
  9. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  10. * History of pneumonitis/interstitial lung disease
  11. * History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  12. * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
  13. * Individual with active uncontrolled infection

Contacts and Locations

Study Contact

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

Advent Health Orlando Hospital
Orlando, Florida, 32804
United States
Advent Health Orlando
Orlando, Florida, 32804
United States
Emory University
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UT Southwestern Medical Center
Dallas, Texas, 75390-8884
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229-3307
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 Date2024-03-05
Study Completion Date2027-03-04

Study Record Updates

Study Start Date2024-03-05
Study Completion Date2027-03-04

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)

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