RecruitingPhase 1NCT06586515

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

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Sponsor

Eli Lilly and Company

Enrollment

630 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LY3962673 that specifically targets a KRAS mutation called G12D — one of the most common cancer-causing mutations found in pancreatic cancer, colorectal cancer, and other solid tumors. This is an early-phase study to determine safe doses and whether the drug is effective. **You may be eligible if...** - You have an advanced or metastatic solid tumor (cancer that has spread and cannot be surgically removed) - Your cancer has a confirmed KRAS G12D mutation in tumor tissue or a blood test - You have received at least one prior line of cancer treatment - Your cancer has measurable disease on imaging - Your overall health is rated 0–1 on standard performance scales **You may NOT be eligible if...** - Your tumor does not have a KRAS G12D mutation - You have untreated or unstable brain metastases - You have active heart disease or recent heart events - You are pregnant or breastfeeding - You have significant liver or kidney dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3962673

Administered orally.

DRUGCetuximab

Administered intravenously.

DRUGGemcitabine

Administered intravenously.

DRUGnab-paclitaxel

Administered intravenously.

DRUGOxaliplatin

Administered intravenously.

DRUGleucovorin

Administered intravenously.

DRUGIrinotecan

Administered intravenously.

DRUG5-fluorouracil

Administered intravenously.

Locations(52)

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA)

Santa Monica, California, United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

Orlando, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Community Health Network

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

New York University (NYU) Langone Medical Center

New York, New York, United States

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

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati (UC) - Cancer Institute

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

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

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

USO - US Oncology Research Network

Nashville, Tennessee, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States

The Ottawa Hospital

Ottawa, Canada

Princess Margaret Hospital

Toronto, Canada

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, China

Beijing Cancer hospital

Beijing, China

Harbin Medical University Cancer Hospita

Harbin, China

Fudan University Cancer Center

Shanghai, China

Centre Leon Berard

Lyon, France

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

Marseille, France

Oncopole Claudius Regaud

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitaetsklinikum Essen

Essen, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Germany

START Dublin Early Phase Clinical Trials Unit

Dublin, Ireland

Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

Naples, Italy

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

Roma, Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, Italy

National Cancer Center Hospital East

Chiba, Japan

Kanagawa cancer center

Kanagawa, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Kansai Medical University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

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

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

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

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06586515

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