A First-in-Human, Phase Ia/Ib Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Study Identifier:
LOXO-FRA-24001 (J5E-OX-JZXA)
CT.gov Identifier:
NCT06400472
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-511238-11-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced 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. Key endpoints were safety, PK, and antitumor activity per RECIST v1.1. Efficacy evaluable pts were those who had a post baseline response assessment or discontinued treatment prior to the response assessment.

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.
  • Ovarian
  • Endometrial
  • Uterine
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Breast Cancers
  • Pancreas
  • Bowel (Colorectal)
    • 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
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Have one of the following solid tumor cancers:
    • Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
    • Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
    • Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC
    Exclusion criteria
    • - Individual with known or suspected uncontrolled central nervous system (CNS)
    • metastases
    • - Individual with history of carcinomatous meningitis
    • - Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic
    • infection
    • - Individual with evidence of corneal keratopathy or history of corneal transplant
    • - Any serious unresolved toxicities from prior therapy
    • - 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 study or
    • within 30 days of last dose of study intervention

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Endometrial
    Uterine
    Solid Tumor
    Non-Small Cell Lung Cancer
    Breast Cancers
    Pancreas
    Bowel (Colorectal)
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Endometrial
    Uterine
    Solid Tumor
    Non-Small Cell Lung Cancer
    Breast Cancers
    Pancreas
    Bowel (Colorectal)