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Brief Title: Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Official Title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Study ID: NCT05245500
Brief Summary: This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.
Detailed Description: This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, 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 MRTX1719.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Phoenix, Arizona, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Mayo Clinic, Jacksonville, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
NorthShore Hematology Oncology Associates P.C New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Oncology Consultants, P.A., Houston, Texas, United States
START Center for Cancer Care, San Antonio, Texas, United States
NEXT Virginia, Fairfax, Virginia, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Bristol-Myers Squibb, MD
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR