A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
NCT ID: NCT06607185
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
750 participants
INTERVENTIONAL
2024-10-21
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LY4066434 Monotherapy Dose Escalation
Escalating doses of LY4066434 administered orally.
LY4066434.
Administered orally.
LY4066434 Dose Optimization
LY4066434 administered orally either alone or with another investigational agent.
LY4066434.
Administered orally.
Cetuximab
Administered intravenously.
Nab paclitaxel
Administered intravenously.
Gemcitabine
Administered intravenously.
Oxaliplatin
Administered intravenously.
Leucovorin
Administered intravenously.
Irinotecan
Administered intravenously.
5Fluorouracil
Administered intravenously.
Carboplatin
Administered intravenously.
Cisplatin
Administered intravenously.
Pemetrexed
Administered intravenously.
Pembrolizumab
Administered intravenously.
Interventions
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LY4066434.
Administered orally.
Cetuximab
Administered intravenously.
Nab paclitaxel
Administered intravenously.
Gemcitabine
Administered intravenously.
Oxaliplatin
Administered intravenously.
Leucovorin
Administered intravenously.
Irinotecan
Administered intravenously.
5Fluorouracil
Administered intravenously.
Carboplatin
Administered intravenously.
Cisplatin
Administered intravenously.
Pemetrexed
Administered intravenously.
Pembrolizumab
Administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 180 days of the last dose of trial intervention
* Must be able to swallow tablets
* Participants with asymptomatic or treated CNS disease may be eligible
Exclusion Criteria
* Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, hearing loss, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
* Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
* Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) or untreated HIV infection
* Have other active malignancy unless in remission with life expectancy greater than 2 years.
* Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Detroit, 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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Related Links
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A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Other Identifiers
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J5Q-OX-JRDA
Identifier Type: OTHER
Identifier Source: secondary_id
27237
Identifier Type: -
Identifier Source: org_study_id