MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Adenocarcinoma

Non-small Cell Lung Cancer

Colon Cancer; Rectal Cancer

Treatment

5-fluorouracil

Gemcitabine

Oxaliplatin

Clinical Study ID

NCT06586515
27189
J5J-OX-JZZA
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess safety & tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Histological or cytologically proven diagnosis of locally advanced,unresectable, and/or metastatic cancer and measurable disease per ResponseEvaluation Criteria in Solid Tumors (RECIST) version 1.1.

  • Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA

  • Have an ECOG performance status of ≤ 1

  • Must have received ≥ 1 prior line of systemic chemotherapy for advanced ormetastatic disease

  • 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 National CancerInstitute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.

  • Have significant cardiovascular disease as unstable angina or acute coronarysyndrome, history of myocardial infarction, known reduced left ventricular ejectionfraction.

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

  • Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).

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

Study Design

Total Participants: 540
Treatment Group(s): 8
Primary Treatment: 5-fluorouracil
Phase: 1
Study Start date:
September 12, 2024
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • The Ottawa General Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Princess Margaret Hospital (Ontario)

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Centre Leon Berard

    Lyon, 69008
    France

    Site Not Available

  • APHM Hôpital de la Timone

    Marseille, 13005
    France

    Site Not Available

  • Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM) - AP-HM Hopital de La Timone

    Marseille, 13005
    France

    Site Not Available

  • APHM Hôpital de la Timone

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • L'Institut Universitaire du Cancer de Toulouse Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Oncopole Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif cedex, 94805
    France

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bayern 80377
    Germany

    Site Not Available

  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    Munchen, 81377
    Germany

    Site Not Available

  • START Dublin Early Phase Clinical Trials Unit

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

    Napoli, 80138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Napoli, 80138
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kanagawa cancer center

    Kanagawa, 241-8515
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577
    Japan

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital

    Osaka, 573-1191
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz-Oncology

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90404
    United States

    Site Not Available

  • University of California, Los Angeles (UCLA)

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • UCLA

    Santa Monica, California 90404
    United States

    Site Not Available

  • City of Hope Medical Group

    South Pasadena, California 91030
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthOne

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • Sibley Memorial Hospital

    Washington DC, District of Columbia 20016
    United States

    Site Not Available

  • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Florida Cancer Specialists Lake Nona Drug Development Unit

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    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

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

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • New York University (NYU) Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Cincinnati (UC) - Cancer Institute

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Sarah Cannon Cancer Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • USO - US Oncology Research Network

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-6307
    United States

    Site Not Available

  • Vanderbilt University School of Medicine

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • START San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53705
    United States

    Site Not Available

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