RecruitingInterventionalPhase 1

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

NCT ID: NCT05245500Sponsor: Bristol-Myers SquibbLast updated: 2025-12-05

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.

Arms & interventions

DrugMRTX1719
MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Outcome measures

Primary

Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 days
Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Number of Patients With Clinically Significant Laboratory Assessments
Time frame: Up to 4 years

Secondary

Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Time frame: Up to 4 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 4 days
Terminal elimination half-life (t1/2)
Time frame: Up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Time frame: Up to 4 days
Apparent volume of distribution when dosed orally (Vz/F)
Time frame: Up to 4 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (25)

Mayo Clinic

Phoenix, Arizona, 85054-4502

Recruiting

Tanios Bekaii-Saab, Site 113 · Contact

480-301-8000

Sarah Cannon Research Institute (SCRI) - HealthONE Location

Denver, Colorado, 80218-1238

Recruiting

Sreenivasa Chandana, Site 106 · Contact

269-993-6056

Rocky Mountain Cancer Centers, LLP - Oncology

Lone Tree, Colorado, 80124

Recruiting

Robert Jotte, Site 109 · Contact

303-430-2700

Mayo Clinic

Jacksonville, Florida, 32224

Recruiting

Hani Babiker, Site 114 · Contact

000000000

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827

Recruiting

Cesar Perez Batista, Site 121 · Contact

Local Institution - 124

Chicago, Illinois, 60637

Withdrawn

Dana-Farber Cancer Institute

Brookline, Massachusetts, 02251

Recruiting

Pasi Janne, Site 103 · Contact

617-632-6036

Cancer and Hematology Centers of Western Michigan

Norton Shores, Michigan, 49444

Recruiting

Sreenivasa Chandana, Site 131 · Contact

269-993-6056

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting

Lei Deng, Site 112 · Contact

206-606-4801

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

Kristen Spencer, Site 127 · Contact

732-235-2465

Local Institution - 129

Mineola, New York, 11501

Not Yet Recruiting

Site 129 · Contact

David H Koch, Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting

Kathryn Arbour, Site 104 · Contact

646-608-3792

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776

Recruiting

Richard Zuniga, Site 101 · Contact

631751050

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776

Recruiting

Richard Zuniga, Site 115 · Contact

University of North Carolina - Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599

Recruiting

Shetal Patel, Site 107 · Contact

University of North Carolina

Chapel Hill, North Carolina, 27599

Recruiting

Shetal Patel, Site 125 · Contact

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232-5505

Recruiting

Elizabeth Davis, Site 132 · Contact

206-341-1111

Ut Southwestern

Dallas, Texas, 75235

Recruiting

Salwan Al Mutar, Site 120 · Contact

Texas Oncology - DFW

Fort Worth, Texas, 76104

Recruiting

Andrew Paulson, Site 111 · Contact

214-370-1000

MDACC

Houston, Texas, 77030

Recruiting

Jordi Ahnert, Site 105 · Contact

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229

Recruiting

Kyriakos Papadopoulos, Site 102 · Contact

Texas Oncology, P.A. - Oncology

Tyler, Texas, 78503

Recruiting

Donald Richards, Site 110 · Contact

903-579-9800

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031

Recruiting

Alexander Spira, Site 122 · Contact

703-280-5390

Local Institution - 134

Seattle, Washington, 98109

Withdrawn

Local Institution - 108

Milwaukee, Wisconsin, 53226

Completed