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

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Active drug More information Started >3 years ago More information High burden on patient More information

Trial Details

Sponsor: Bristol-Myers Squibb (industry)

Phase: 1

Start date: June 9, 2022

Planned enrollment: 320

Trial ID: NCT05245500
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: BMS-986504 (MRTX1719)

TrialFetch AI Analysis

Goal: Determine the safety, tolerability, dosing, pharmacokinetics, pharmacodynamics, and antitumor activity of MRTX1719 in advanced MTAP-deleted solid tumors.

Patients: Adults with unresectable or metastatic solid tumors harboring homozygous MTAP deletion, ECOG performance status 0–1, and adequate organ function. Patients previously treated with a PRMT5 or MAT2A inhibitor or with active brain metastases are excluded.

Design: First-in-human, open-label, multicenter, nonrandomized dose-escalation and regimen-evaluation study with expansion cohorts. A sub-study evaluates combinations with standard-of-care therapy in selected tumor types.

Treatments: MRTX1719 (BMS-986504) is an investigational oral inhibitor designed to target the PRMT5–MTA complex that accumulates in MTAP-deleted tumors. An interim, nonrandomized analysis reported a 23% objective response rate and 70% disease control rate across evaluated tumor types; these findings do not establish comparative efficacy. The sub-study combines MRTX1719 with standard-of-care therapy.

Outcomes: Primary measures include dose-limiting toxicities during the first 21 days, treatment-related adverse events, objective response rate, duration of response, progression-free survival, and overall survival. Secondary measures characterize plasma pharmacokinetics, including exposure, peak concentration, time to peak, half-life, clearance, and volume of distribution.

Burden on patient: High. Baseline and on-treatment tumor biopsies are generally required, and early pharmacokinetic sampling may involve frequent blood draws and visits. Dose-escalation safety monitoring and ongoing tumor assessments add to travel and time commitments.

Last updated: Sep 2026

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Sites (25)

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Mayo Clinic

Phoenix, Arizona, 85054-4502, United States

No email / 480-301-8000

Status: Recruiting

Rocky Mountain Cancer Centers, LLP - Oncology

Lone Tree, Colorado, 80124, United States

No email / 303-430-2700

Status: Recruiting

Sarah Cannon Research Institute (SCRI) - HealthONE Location

Denver, Colorado, 80218-1238, United States

No email / 269-993-6056

Status: Recruiting

Mayo Clinic

Jacksonville, Florida, 32224, United States

No email / 000000000

Status: Recruiting

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

No email / No phone

Status: Recruiting

Dana-Farber Cancer Institute

Brookline, Massachusetts, 02251, United States

No email / 617-632-6036

Status: Recruiting

Cancer and Hematology Centers of Western Michigan

Norton Shores, Michigan, 49444, United States

No email / 269-993-6056

Status: Recruiting

Mayo Clinic

Rochester, Minnesota, 55905, United States

No email / 206-606-4801

Status: Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

No email / 732-235-2465

Status: Recruiting

David H Koch, Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

No email / 646-608-3792

Status: Recruiting

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776, United States

No email / 631751050

Status: Recruiting

New york cancer and blood specialists - Oncology

Port Jefferson Station, New York, 11776, United States

No email / No phone

Status: Recruiting

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

No email / No phone

Status: Recruiting

University of North Carolina - Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599, United States

No email / No phone

Status: Recruiting

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232-5505, United States

No email / 206-341-1111

Status: Recruiting

MDACC

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

No email / No phone

Status: Recruiting

Texas Oncology - DFW

Fort Worth, Texas, 76104, United States

No email / 214-370-1000

Status: Recruiting

Texas Oncology, P.A. - Oncology

Tyler, Texas, 78503, United States

No email / 903-579-9800

Status: Recruiting

Ut Southwestern

Dallas, Texas, 75235, United States

No email / No phone

Status: Recruiting

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

No email / 703-280-5390

Status: Recruiting

Local Institution - 129

Mineola, New York, 11501, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 108

Milwaukee, Wisconsin, 53226, United States

No email / No phone

Status: Completed

Local Institution - 124

Chicago, Illinois, 60637, United States

No email / No phone

Status: Withdrawn

Local Institution - 134

Seattle, Washington, 98109, United States

No email / No phone

Status: Withdrawn

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