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NCT05245500PHASE1Recruiting

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Bristol-Myers Squibb

Start Date

6/9/2022

Completion Date

12/10/2027

Summary

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

MRTX1719

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Conditions

MesotheliomaNon Small Cell Lung CancerMalignant Peripheral Nerve Sheath TumorsSolid TumorPancreatic AdenocarcinomaAdvanced Solid Tumor

Locations

Mayo Clinic

Phoenix, Arizona 85054-4502

United States

Sarah Cannon Research Institute (SCRI) - HealthONE Location

Denver, Colorado 80218-1238

United States

Rocky Mountain Cancer Centers, LLP - Oncology

Lone Tree, Colorado 80124

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida 32827

United States

Local Institution - 124

Chicago, Illinois 60637

United States

Dana-Farber Cancer Institute

Brookline, Massachusetts 02251

United States

Cancer and Hematology Centers of Western Michigan

Norton Shores, Michigan 49444

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Local Institution - 129

Mineola, New York 11501

United States

David H Koch, Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York 11776

United States

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York 11776

United States

University of North Carolina - Gastroenterology and Hepatology

Chapel Hill, North Carolina 27599

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee 37232-5505

United States

Ut Southwestern

Dallas, Texas 75235

United States

Texas Oncology - DFW

Fort Worth, Texas 76104

United States

MDACC

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas 78229

United States

Texas Oncology, P.A. - Oncology

Tyler, Texas 78503

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Local Institution - 134

Seattle, Washington 98109

United States

Local Institution - 108

Milwaukee, Wisconsin 53226

United States