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RECRUITINGPhase 1INTERVENTIONAL

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria - diagnosed by tissue sample (biopsy-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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests. 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

MRTX1719

MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Locations (20)

Mayo Clinic
Phoenix, Arizona, United States
Sarah Cannon Research Institute (SCRI) - HealthONE Location
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP - Oncology
Lone Tree, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Local Institution - 124
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Brookline, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan
Norton Shores, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Local Institution - 129
Mineola, New York, United States
David H Koch, Memorial Sloan Kettering Cancer Center
New York, New York, United States
New york cancer and blood specialists - Oncology
Port Jefferson Station, New York, United States
New york cancer and blood specialists - Oncology
Port Jefferson Station, New York, United States
University of North Carolina - Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
Ut Southwestern
Dallas, Texas, United States
Texas Oncology - DFW
Fort Worth, Texas, United States
MDACC
Houston, Texas, United States