ClinicalTrials.gg
RecruitingNCT05245500Updated Sep 2, 2026

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

A Phase 1 interventional study of MRTX1719 in Mesothelioma, Non Small Cell Lung Cancer and Malignant Peripheral Nerve Sheath Tumors, sponsored by Bristol-Myers Squibb. Recruiting at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
336
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mesothelioma
  • Non Small Cell Lung Cancer
  • Malignant Peripheral Nerve Sheath Tumors
  • Solid Tumor
  • Pancreatic Adenocarcinoma
  • Advanced Solid Tumor

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
03

In context

Mesothelioma

305 studies on the registry are indexed under Mesothelioma; 61 are open to participants now.

This study's planned enrollment of 336 is above the median of 48 across 250 interventional studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.

Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed diagnosis of a solid tumor with homozygous deletion of the MTAP gene detected in tumor tissue.
  • Unresectable or disease.
  • Presence of a tumor lesion amenable to mandatory for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
  • Age ≥ 18 years.
  • (ECOG) performance status of 0 or 1.
  • Adequate organ function.

Exclusion criteria

Exclusion Criteria

  • Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
  • Active 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
336 participants (estimated)

Study arms

  • Experimental
    Phase 1/1B

    Dose Escalation/Evaluation

    Drug: MRTX1719

  • Experimental
    Phase 1b Sub-studies 1-4

    Drug: MRTX1719

  • Experimental
    Phase 1b Sub-study 5

    Drug: MRTX1719

Interventions

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

06

What researchers measure

Primary outcomes

  1. Number of Patients who Experience Dose-Limiting Toxicity

    Time frame: 21 days

  2. Number of patients who experience a treatment-related adverse event

    Time frame: Up to 2 years

  3. Objective response rate (ORR)

    Time frame: 2 years

  4. Duration of response (DOR)

    Time frame: 2 years

  5. Progression free survival (PFS)

    Time frame: 2 years

  6. Overall survival (OS)

    Time frame: 2 years

  7. Number of Patients With Clinically Significant Laboratory Assessments

    Time frame: Up to 4 years

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 4 days

  2. Time to achieve maximal plasma concentration (Tmax)

    Time frame: Up to 4 days

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 4 days

  4. Terminal elimination half-life (t1/2)

    Time frame: Up to 4 days

  5. Apparent total plasma clearance when dosed orally (CL/F)

    Time frame: Up to 4 days

  6. Apparent volume of distribution when dosed orally (Vz/F)

    Time frame: Up to 4 days

07

Study locations

22 of 25 sites recruiting
  • Mayo Clinic
    Phoenix, Arizona 85054-4502, United States
    Recruiting
    • Tanios Bekaii-Saab, Site 113 · Contact480-301-8000
  • Rocky Mountain Cancer Centers, LLP - Oncology
    Lone Tree, Colorado 80124, United States
    Recruiting
    • Robert Jotte, Site 109 · Contact303-430-2700
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Recruiting
    • Hani Babiker, Site 114 · Contact000000000
  • Sarah Cannon Research Institute at Florida Cancer Specialists
    Orlando, Florida 32827, United States
    Recruiting
    • Cesar Perez Batista, Site 121 · Contact
  • Local Institution - 124
    Chicago, Illinois 60637, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Dana-Farber Cancer Institute
    Brookline, Massachusetts 02251, United States
    Recruiting
    • Pasi Janne, Site 103 · Contact617-632-6036
  • The Cancer & Hematology Centers
    Grand Rapids, Michigan 49546, United States
    Recruiting
    • Sreenivasa Chandana, Site 106 · Contact269-993-6056
  • Cancer and Hematology Centers of Western Michigan
    Norton Shores, Michigan 49444, United States
    Recruiting
    • Sreenivasa Chandana, Site 131 · Contact269-993-6056
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
    • Lei Deng, Site 112 · Contact206-606-4801
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08901, United States
    Recruiting
    • Kristen Spencer, Site 127 · Contact732-235-2465
  • Perlmutter Cancer Center at NYU Langone Hospital Long Island
    Mineola, New York 11501, United States
    Recruiting
    • Kristen Spencer, Site 129 · Contact732-235-2465
  • David H Koch, Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
    Recruiting
    • Kathryn Arbour, Site 104 · Contact646-608-3792
  • New york cancer and blood specialists - Oncology
    Port Jefferson Station, New York 11776, United States
    Recruiting
    • Richard Zuniga, Site 101 · Contact631751050
  • New york cancer and blood specialists - Oncology
    Port Jefferson Station, New York 11776, United States
    Recruiting
    • Richard Zuniga, Site 115 · Contact
  • University of North Carolina - Gastroenterology and Hepatology
    Chapel Hill, North Carolina 27599, United States
    Recruiting
    • Shetal Patel, Site 107 · Contact
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
    Recruiting
    • Shetal Patel, Site 125 · Contact
  • Vanderbilt - Ingram Cancer Center
    Nashville, Tennessee 37232-5505, United States
    Recruiting
    • Elizabeth Davis, Site 132 · Contact206-341-1111
  • Ut Southwestern
    Dallas, Texas 75235, United States
    Recruiting
    • Salwan Al Mutar, Site 120 · Contact
  • Texas Oncology - DFW
    Fort Worth, Texas 76104, United States
    Recruiting
    • Andrew Paulson, Site 111 · Contact214-370-1000
  • MDACC
    Houston, Texas 77030, United States
    Recruiting
    • Jordi Ahnert, Site 105 · Contact
  • South Texas Accelerated Research Therapeutics
    San Antonio, Texas 78229, United States
    Recruiting
    • Kyriakos Papadopoulos, Site 102 · Contact
  • Texas Oncology, P.A. - Oncology
    Tyler, Texas 78503, United States
    Recruiting
    • Donald Richards, Site 110 · Contact903-579-9800
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
    Recruiting
    • Alexander Spira, Site 122 · Contact703-280-5390
  • Local Institution - 134
    Seattle, Washington 98109, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Local Institution - 108
    Milwaukee, Wisconsin 53226, United States
    Completed

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05245500
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Jun 9, 2022
Primary completion
Dec 10, 2027 (estimated)
Completion
Dec 10, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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