RECRUITING

A Study of LY4175408 in Participants With Advanced Cancer

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Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaEndometrial NeoplasmsNeoplasm MetastasisTriple Negative Breast Cancer

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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 measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.

Official Title

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Quick Facts

Study Start:2025-07-28
Study Completion:2030-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07046923

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 advanced or metastatic solid tumor cancers:
  2. * Non-small cell lung cancer (NSCLC)
  3. * Small cell lung cancer (SCLC)
  4. * Endometrial cancer
  5. * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).
  6. * Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator; OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  8. * For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  1. * Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted).
  2. * Any serious unresolved toxicities from prior therapy.
  3. * Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.
  4. * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
  5. * Significant cardiovascular disease.
  6. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms)
  7. * History of pneumonitis/interstitial lung disease.
  8. * Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

Contacts and Locations

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
CONTACT
clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Stanford Cancer Center
Stanford, California, 94305
United States
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, 32827
United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34236
United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
United States
Community Health Network
Indianapolis, Indiana, 46250
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University
St Louis, Missouri, 63110
United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, 07601
United States
Columbia University
New York, New York, 10032
United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, 43210
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
START Mountain Region
West Valley City, Utah, 84119
United States
NEXT Virginia
Fairfax, Virginia, 22031
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 8 AM - 8 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 Date2025-07-28
Study Completion Date2030-07

Study Record Updates

Study Start Date2025-07-28
Study Completion Date2030-07

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Small Cell Lung Carcinoma
  • Endometrial Neoplasms
  • Neoplasm Metastasis
  • Triple Negative Breast Cancer