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

Last updated: January 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Vaginal Cancer

Head And Neck Cancer

Treatment

LY4101174

Clinical Study ID

NCT06238479
LOXO-ENC-23001
2023-509867-26-00
J5A-OX-JZWA
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have one of the following solid tumor cancers:

  • Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small celllung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervicalcancer (squamous cell carcinoma), head and neck squamous cell carcinoma orprostate cancer

  • Cohort A2/B1/B2: urothelial carcinoma

  • Cohort C1: triple negative breast cancer

  • Cohort C2: non-small cell lung cancer

  • Cohort C3: ovarian or fallopian tube cancer

  • Cohort C4: cervical cancer

  • Cohort C5: head and neck squamous cell carcinoma

  • Prior Systemic Therapy Criteria:

  • Cohort A1/C1-5: Individual has received all standard therapies for which theparticipant was deemed to be an appropriate candidate by the treatinginvestigator; OR there is no standard therapy available for the disease. Thereis no restriction on number of prior therapies

  • Cohort A2/B1/B2: Individual must have received at least one prior regimen inthe advanced or metastatic setting. There is no restriction on number of priortherapies.

  • Prior enfortumab vedotin specific requirements:

  • Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but notrequired

  • Cohort B1: individual must be enfortumab vedotin naive in theadvanced/metastatic setting

  • Cohort B2: individual must have received enfortumab vedotin in themetastatic/advanced setting.

  • Measurability of disease

  • Cohort A1: measurable or non-measurable disease as defined by ResponseEvaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)

  • Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Have adequate archival tumor tissue sample available or undergo a screening biopsyif allowed per country specific regulations

Exclusion

Exclusion Criteria:

  • Individual with known or suspected uncontrolled CNS metastases

  • Individual with uncontrolled hypercalcemia

  • Individual with uncontrolled diabetes

  • Individual with evidence of corneal keratopathy or history of corneal transplant

  • Any serious unresolved toxicities from prior therapy

  • Significant cardiovascular disease

  • Current of history of intestinal obstruction in the previous 3 months

  • Recent thromboembolic event or bleeding disorder

  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms

  • History of pneumonitis/interstitial lung disease

  • History of Grade ≥3 skin toxicity when receiving enfortumab vedotin

  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study orwithin 30 days of last dose of study intervention

  • Individual with active uncontrolled infection

Study Design

Total Participants: 490
Treatment Group(s): 1
Primary Treatment: LY4101174
Phase: 1
Study Start date:
March 05, 2024
Estimated Completion Date:
March 04, 2027

Study Description

This is a Phase 1a/1b multicenter, open-label study in participants with select advanced or metastatic solid tumors. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history.

Connect with a study center

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia 5037
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Institut Jules Bordet

    Brussels, 1070
    Belgium

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Koto City, Tokyo 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, 104-0045
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Advent Health Orlando

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Advent Health Orlando Hospital

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • New York University Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27599-7305
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390-8884
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 78229-3307
    United States

    Active - Recruiting

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