A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

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

Phase

1

Condition

Colon Cancer

Pancreatic Cancer

Colon Cancer; Rectal Cancer

Treatment

Cisplatin

Gemcitabine

Cetuximab

Clinical Study ID

NCT06607185
27237
J5Q-OX-JRDA
  • Ages > 18
  • All Genders

Study Summary

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissueor circulating tumor DNA

  • Histological or cytologically proven diagnosis of a locally advanced, unresectable,and/or metastatic solid tumor cancer

  • Have measurable disease per RECIST 1.1

  • Have an ECOG performance status of ≤1

  • Must not be pregnant and/or planning to breastfeed during the trial or within 180days of the last dose of trial intervention

  • Must be able to swallow tablets

  • Participants with asymptomatic or treated CNS disease may be eligible

Exclusion

Exclusion Criteria:

  • Have known active CNS metastases and/or carcinomatous meningitis

  • Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0Grade 1 at the time of starting trial treatment, except for alopecia, peripheralneuropathy and ongoing endocrinopathies controlled on appropriate replacementtherapy

  • Have significant cardiovascular disease defined as unstable angina or acute coronarysyndrome, history of myocardial infarction, known left ventricular ejection fractionor heart failure, uncontrolled or symptomatic arrhythmias.

  • Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) and untreated HIVinfection

  • Have other active malignancy unless in remission with life expectancy greater than 2years.

  • Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

  • Have history of non-infectious pneumonitis/interstitial lung disease that receivedsteroids or has current clinically significant pneumonitis/interstitial lung disease

Study Design

Total Participants: 750
Treatment Group(s): 12
Primary Treatment: Cisplatin
Phase: 1
Study Start date:
October 21, 2024
Estimated Completion Date:
January 31, 2030

Connect with a study center

  • Cliniques universitaires Saint-Luc

    Bruxelles, Brussel 1200
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussel - Capital, 1070
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universite Libre de Bruxelles (ULB) - Institut Jules Bordet

    Brussels, 1070
    Belgium

    Site Not Available

  • University Hospital Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Institut Gustave Roussy

    Villejuif cedex, 94805
    France

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • SLK-Kliniken Heilbronn GmBH

    Heilbronn, 74078
    Germany

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97080
    Germany

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Tominaga Hospital

    Sunto-Gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Koto City, Tokyo 135-8550
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Shizuoka, 411-8777
    Japan

    Site Not Available

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Malaga, 29010
    Spain

    Site Not Available

  • Hsin-Chu Hospital

    Hsin-chu, 300
    Taiwan

    Site Not Available

  • National Taiwan University Hospital Hsin-Chu Branc

    Hsinchu, 300195
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • University of Alabama Birmingham

    Birmingham, Alabama 35233-2028
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010-0269
    United States

    Site Not Available

  • University of California, Los Angeles (UCLA)

    Los Angeles, California 90025
    United States

    Site Not Available

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • University of Colorado Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • Yale University School of Medicine - Yale Cancer Center

    New Haven, Connecticut 06520-8028
    United States

    Site Not Available

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Indiana University (IU)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering

    New York, New York 10021
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Texas Southwestern

    Dallas, Texas 75238
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75390-9063
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START

    San Antonio, Texas 78229-3307
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • USO-Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

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