A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic
RECRUITING
Phoenix
California
City of Hope
RECRUITING
Duarte
University of California, Los Angeles (UCLA)
RECRUITING
Los Angeles
Colorado
University of Colorado Denver
NOT_YET_RECRUITING
Denver
Connecticut
Yale University School of Medicine - Yale Cancer Center
RECRUITING
New Haven
Illinois
The University of Chicago Medical Center (UCMC)
NOT_YET_RECRUITING
Chicago
Indiana
Indiana University (IU)
RECRUITING
Indianapolis
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
South Texas Accelerated Research Therapeutics (START) Midwest
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic - Rochester
NOT_YET_RECRUITING
Rochester
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Columbia University
RECRUITING
New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
University of Oklahoma - Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas Southwestern
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
South Texas Accelerated Research Therapeutics (START)
RECRUITING
San Antonio
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Swedish Cancer Institute (SCI)
RECRUITING
Seattle
Other Locations
Belgium
Cliniques universitaires Saint-Luc
RECRUITING
Brussels
Universite Libre de Bruxelles (ULB) - Institut Jules Bordet
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
China
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital, College of Medicine, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Shandong Province Tumor Hospital
NOT_YET_RECRUITING
Jinan
Shanghai East Hospital, Tongji University
NOT_YET_RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
France
Centre Leon Berard
NOT_YET_RECRUITING
Lyon
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Charite Universitaetsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt
Asklepios Kliniken Hamburg GmbH - Asklepios Klinik Altona
RECRUITING
Hamburg
SLK-Kliniken Heilbronn GmBH
RECRUITING
Heilbronn
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Italy
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Japan
National Cancer Center Hospital East
RECRUITING
Chiba
Kyoto University Hospital
RECRUITING
Kyoto
Shizuoka Cancer Center
RECRUITING
Shizuoka
Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
National Cancer Center Hospital
RECRUITING
Tokyo
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Institut Catala d'Oncologia - L'Hospitalet
NOT_YET_RECRUITING
Barcelona
Hospital General Universitario Gregorio Maranon
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Taiwan
National Taiwan University Hospital Hsin-Chu Branch
RECRUITING
Hsinchu
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2030-01
Participants
Target number of participants: 750
Treatments
Experimental: LY4066434 Monotherapy Dose Escalation
Escalating doses of LY4066434 administered orally.
Experimental: LY4066434 Dose Optimization
LY4066434 administered orally either alone or with another investigational agent.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company