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ACTIVE NOT RECRUITING
NCT06607185
PHASE1

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2024-10-21

Completion Date

2030-01

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

LY4066434.

Administered orally.

DRUG

Cetuximab

Administered intravenously.

DRUG

Nab paclitaxel

Administered intravenously.

DRUG

Gemcitabine

Administered intravenously.

DRUG

Oxaliplatin

Administered intravenously.

DRUG

Leucovorin

Administered intravenously.

DRUG

Irinotecan

Administered intravenously.

DRUG

5Fluorouracil

Administered intravenously.

DRUG

Carboplatin

Administered intravenously.

DRUG

Cisplatin

Administered intravenously.

DRUG

Pemetrexed

Administered intravenously.

DRUG

Pembrolizumab

Administered intravenously.

Locations (56)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic

Phoenix, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

University of Colorado Denver

Denver, Colorado, United States

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

Indiana University (IU)

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detriot, Michigan, United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University

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

Cleveland Clinic

Cleveland, Ohio, United States

University of Oklahoma - Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Swedish Cancer Institute (SCI)

Seattle, Washington, United States

Universite Libre de Bruxelles (ULB) - Institut Jules Bordet

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, China

Shandong Province Tumor Hospital

Jinan, China

Shanghai East Hospital, Tongji University

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Centre Leon Berard

Lyon, France

Institut Gustave Roussy

Villejuif, France

Charite Universitaetsmedizin Berlin

Berlin, Germany

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona

Hamburg, Germany

SLK-Kliniken Heilbronn GmBH

Heilbronn, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Centro Ricerche Cliniche di Verona s.r.l.

Verona, Italy

National Cancer Center Hospital East

Chiba, Japan

Kyoto University Hospital

Kyoto, Japan

Shizuoka Cancer Center

Shizuoka, Japan

National Cancer Center Hospital

Tokyo, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

National Taiwan University Hospital

Taipei, Taiwan