Recruiting
Phase 1

MRTX1719

Sponsor:

Bristol-Myers Squibb

Code:

NCT05245500

Conditions

Mesothelioma

Non Small Cell Lung Cancer

Malignant Peripheral Nerve Sheath Tumors

Solid Tumor

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRTX1719

Study Details

Brief 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.

Conditions

Mesothelioma

Non Small Cell Lung Cancer

Malignant Peripheral Nerve Sheath Tumors

Solid Tumor

Pancreatic Adenocarcinoma

Study ID

NCT05245500

Start date

Jun 9, 2022

Status verified date

Aug, 2026

Completion date

Dec 10, 2027

Anticipated

Primary completion date

Dec 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

336 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1/1B

Dose Escalation/Evaluation

experimental: Phase 1b Sub-studies 1-4

experimental: Phase 1b Sub-study 5

Interventions

MRTX1719

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054-4502

Contacts

Tanios Bekaii-Saab, Site 113

480-301-8000

Rocky Mountain Cancer Centers, LLP - Oncology

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Robert Jotte, Site 109

303-430-2700

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Hani Babiker, Site 114

000000000

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Dana-Farber Cancer Institute

Recruiting

Brookline, Massachusetts, United States, 02251

Contacts

Pasi Janne, Site 103

617-632-6036

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Sreenivasa Chandana, Site 106

269-993-6056

Cancer and Hematology Centers of Western Michigan

Recruiting

Norton Shores, Michigan, United States, 49444

Contacts

Sreenivasa Chandana, Site 131

269-993-6056

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lei Deng, Site 112

206-606-4801

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Kristen Spencer, Site 127

732-235-2465

Perlmutter Cancer Center at NYU Langone Hospital Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Kristen Spencer, Site 129

732-235-2465

David H Koch, Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Kathryn Arbour, Site 104

646-608-3792

New york cancer and blood specialists - Oncology

Recruiting

Port Jefferson Station, New York, United States, 11776

Contacts

Richard Zuniga, Site 101

631751050

New york cancer and blood specialists - Oncology

Recruiting

Port Jefferson Station, New York, United States, 11776

University of North Carolina - Gastroenterology and Hepatology

Recruiting

Chapel Hill, North Carolina, United States, 27599

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Vanderbilt - Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232-5505

Contacts

Elizabeth Davis, Site 132

206-341-1111

Ut Southwestern

Recruiting

Dallas, Texas, United States, 75235

Texas Oncology - DFW

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Andrew Paulson, Site 111

214-370-1000

MDACC

Recruiting

Houston, Texas, United States, 77030

South Texas Accelerated Research Therapeutics

Recruiting

San Antonio, Texas, United States, 78229

Texas Oncology, P.A. - Oncology

Recruiting

Tyler, Texas, United States, 78503

Contacts

Donald Richards, Site 110

903-579-9800

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Alexander Spira, Site 122

703-280-5390

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • MTAP Deletion
  • Mesothelioma
  • Non Small Cell Lung Cancer
  • Malignant Peripheral Nerve Sheath Tumors
  • Solid Tumor
  • MTAP
  • Malignant
  • Pancreatic adenocarcinoma
  • Pancreas Cancer
  • PRMT5
  • Synthetic Lethality
  • Advanced Solid Tumor
  • NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-02.