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Brief Title: Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Official Title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Study ID: NCT05737706
Brief Summary: A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
Detailed Description: This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital, Phoenix, Arizona, United States
Yale University, Yale Cancer Center, New Haven, Connecticut, United States
Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
START Midwest, Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
SCRI - TN Oncology Nashville Drug Development Unit Clinic, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
NEXT Oncology Virginia, Fairfax, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Name: Hirak Der-Torossian, MD
Affiliation: Mirati Therapeutics Inc.
Role: STUDY_DIRECTOR