A First-in-Human, Phase Ia/Ib 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

Study Identifier:
J6D-MC-JSDA
CT.gov Identifier:
NCT07046923
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521916-20-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Small Cell Lung
  • Endometrial
  • Metastatic Cancer
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a Dose Escalation (Cohort A1)
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  • Drug: Experimental: Phase 1a Dose Optimization (Cohort A2)
  • Drug: Experimental: Phase 1b Dose Expansion (Cohort B)
  • Drug: Study Arms]
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Have one of the following advanced or metastatic solid tumor cancers:
    • * Non-small cell lung cancer (NSCLC)
    • * Small cell lung cancer (SCLC)
    • * Endometrial cancer
    • * 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).
    • * 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.
    • * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
    • * For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    Exclusion criteria
    • * 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). * Any serious unresolved toxicities from prior therapy. * Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases. * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. * Significant cardiovascular disease. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds (ms) * History of pneumonitis/interstitial lung disease. * Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Small Cell Lung
    Endometrial
    Metastatic Cancer
    Breast Cancers