A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Last updated: April 22, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Endometrial Cancer

Ovarian Cysts

Cervical Cancer

Treatment

LY4170156

Bevacizumab

carboplatin

Clinical Study ID

NCT06400472
18863
J5E-OX-JZXA
2024-511238-11-00
LOXO-FRA-24001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have one of the following solid tumor cancers:

  • Cohort A1: 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, and colorectalcancer (CRC)

  • Cohort A2/A3/A4/A5/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, andfallopian tube) cancer

  • Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC orpancreatic cancer

Exclusion

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 parasiticinfection

  • 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 orwithin 30 days of last dose of study intervention

Study Design

Total Participants: 360
Treatment Group(s): 3
Primary Treatment: LY4170156
Phase: 1
Study Start date:
May 20, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Icon Cancer Centre South Brisbane Loc. 10

    South Brisbane, Queensland 4066
    Australia

    Active - Recruiting

  • Cancer Research SA

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Centre Leon Berard

    Lyon, Rhône 69373
    France

    Active - Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

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