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NCT06586515PHASE1Recruiting

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

Eli Lilly and Company

Start Date

9/12/2024

Completion Date

3/1/2029

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

Age Range: 18 years to No maximum

Inclusion Criteria: * Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation 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 or metastatic disease * Participants with asymptomatic or treated CNS disease may be eligible. Exclusion Criteria: * Have known active CNS metastases and/or carcinomatous meningitis. * Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1. * Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction. * 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.

Interventions

DRUG

LY3962673

DRUG

Cetuximab

DRUG

Gemcitabine

DRUG

nab-paclitaxel

DRUG

Oxaliplatin

DRUG

leucovorin

DRUG

Irinotecan

DRUG

5-fluorouracil

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Conditions

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal Cancer

Locations

City of Hope

Duarte, California 91010

United States

University of California, Los Angeles (UCLA)

Santa Monica, California 90404

United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado 80218

United States

Sibley Memorial Hospital

Washington D.C., District of Columbia 20016

United States

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

Orlando, Florida 32827

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

Community Health Network

Indianapolis, Indiana 46250

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan 49546

United States

New York University (NYU) Langone Medical Center

New York, New York 10016

United States

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

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

University of Cincinnati (UC) - Cancer Institute

Cincinnati, Ohio 45267

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

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

Pittsburgh, Pennsylvania 15232

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

USO - US Oncology Research Network

Nashville, Tennessee 37203

United States

Vanderbilt University School of Medicine

Nashville, Tennessee 37215

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas 78229

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin 53792

United States

The Ottawa Hospital

Ottawa, K1H 8L6

Canada

Princess Margaret Hospital

Toronto, M5G 2M9

Canada

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, 100021

China

Beijing Cancer hospital

Beijing, 100142

China

Harbin Medical University Cancer Hospita

Harbin, 150081

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Centre Leon Berard

Lyon, 69373

France

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

Marseille, 13005

France

Oncopole Claudius Regaud

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94805

France

Charite Universitaetsmedizin Berlin

Berlin, 10117

Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, 81377

Germany

START Dublin Early Phase Clinical Trials Unit

Dublin, D07 R2WY

Ireland

Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

Naples, 80138

Italy

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

Roma, 00168

Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134

Italy

National Cancer Center Hospital East

Chiba, 277-8577

Japan

Kanagawa cancer center

Kanagawa, 241-8515

Japan

Aichi Cancer Center Hospital

Nagoya, 464-8681

Japan

Kansai Medical University Hospital

Osaka, 573-1191

Japan

National Cancer Center Hospital

Tokyo, 104-0045

Japan

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

Barcelona, 08023

Spain

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

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

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain