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Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Trial Status: active
This is a Phase 1, 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.
Inclusion Criteria
Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
Unresectable or metastatic disease.
Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function.
Exclusion Criteria
Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
Active brain metastases or carcinomatous meningitis.
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
Major surgery within 4 weeks of first dose of study treatment.
History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Cardiac abnormalities.
Other protocol-defined Inclusion/Exclusion criteria apply.
Additional locations may be listed on ClinicalTrials.gov for NCT05245500.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Approved
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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