Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

April 14, 2025 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054-4502
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Tanios Bekaii-Saab, Site 113
          • Phone Number: 480-301-8000
    • Colorado
      • Denver, Colorado, United States, 80218-1238
        • Recruiting
        • Sarah Cannon Research Institute (SCRI) - HealthONE Location
        • Contact:
          • Jason Henry, Site 106
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP - Oncology
        • Contact:
          • Robert Jotte, Site 109
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Hani Babiker, Site 114
          • Phone Number: 000000000
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute at Florida Cancer Specialists
        • Contact:
          • Cesar Perez Batista, Site 121
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • Local Institution - 124
    • Massachusetts
      • Brookline, Massachusetts, United States, 02251
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Pasi Janne, Site 103
          • Phone Number: 617-632-6036
    • Michigan
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan
        • Contact:
          • Sreenivasa Chandana, Site 131
          • Phone Number: 269-993-6056
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Konstantinos Leventakos, Site 112
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Kristen Spencer, Site 127
          • Phone Number: 732-235-2465
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • David H Koch, Memorial Sloan Kettering Cancer Center
        • Contact:
          • Kathryn Arbour, Site 104
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • New york cancer and blood specialists - Oncology
        • Contact:
          • Richard Zuniga, Site 115
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • Local Institution - 125
        • Contact:
          • Site 125
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI
        • Contact:
          • Melissa Johnson, Site 101
          • Phone Number: 615-329-7274
      • Nashville, Tennessee, United States, 37232-5505
        • Not yet recruiting
        • Local Institution - 132
        • Contact:
          • Site 132
    • Texas
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • Local Institution - 120
        • Contact:
          • Site 120
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology - DFW
        • Contact:
          • Andrew Paulson, Site 111
          • Phone Number: 214-370-1000
      • Houston, Texas, United States, 77030
        • Recruiting
        • MDACC
        • Contact:
          • Jordi Ahnert, Site 105
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants - Clinical Research
        • Contact:
          • Mahran Shoukier, Site 108
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics
        • Contact:
          • Kyriakos Papadopoulos, Site 102
      • Tyler, Texas, United States, 78503
        • Recruiting
        • Texas Oncology, P.A. - Oncology
        • Contact:
          • Donald Richards, Site 110
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC
        • Contact:
          • Alexander Spira, Site 122
          • Phone Number: 703-280-5390
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Local Institution - 134
        • Contact:
          • Site 134
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin - Froedtert Hospital
        • Contact:
          • Ben George, Site 107
          • Phone Number: 414-805-4600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1/1B
Dose Escalation/Evaluation
Drug: MRTX1719

MRTX1719 is a potent PRMT5-MTA inhibitor

Specified dose on specified days
Experimental: Phase 1b Sub-Study
MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion
Drug: MRTX1719

MRTX1719 is a potent PRMT5-MTA inhibitor

Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: 2 years
2 years
Overall survival (OS)
Time Frame: 2 years
2 years
Duration of response (DOR)
Time Frame: 2 years
2 years
Objective response rate (ORR)
Time Frame: 2 years
2 years
Number of Patients who Experience Dose-Limiting Toxicity
Time Frame: 21 days
21 days
Number of patients who experience a treatment-related adverse event
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA240-0007 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 1719-001 (Other Identifier: Mirati Therapeutics Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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