MesotheliomaPhase 1NCT05245500
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
A Phase 1 study testing MRTX1719 in people with Mesothelioma and Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 25 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors
- What is being tested?
- MRTX1719
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 25 sitesUnited States
- Study dates
- 9 Jun 2022to 10 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
25 sites in 1 country
United States25 sites, 22 recruiting
- Recruiting
Dana-Farber Cancer Institute
Brookline, Massachusetts, 02251
Pasi Janne, Site 103, 617-632-6036
- Recruiting
University of North Carolina - Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599
Shetal Patel, Site 107
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Shetal Patel, Site 125
- Withdrawn
Local Institution - 124
Chicago, Illinois, 60637
- Recruiting
Ut Southwestern
Dallas, Texas, 75235
Salwan Al Mutar, Site 120
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Alexander Spira, Site 122, 703-280-5390
- Recruiting
Texas Oncology - DFW
Fort Worth, Texas, 76104
Andrew Paulson, Site 111, 214-370-1000
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546
Sreenivasa Chandana, Site 106, 269-993-6056
- Recruiting
MDACC
Houston, Texas, 77030
Jordi Ahnert, Site 105
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Hani Babiker, Site 114, 000000000
- Recruiting
Rocky Mountain Cancer Centers, LLP - Oncology
Lone Tree, Colorado, 80124
Robert Jotte, Site 109, 303-430-2700
- Completed
Local Institution - 108
Milwaukee, Wisconsin, 53226
- Recruiting
Perlmutter Cancer Center at NYU Langone Hospital Long Island
Mineola, New York, 11501
Kristen Spencer, Site 129, 732-235-2465
- Recruiting
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232-5505
Elizabeth Davis, Site 132, 206-341-1111
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Kristen Spencer, Site 127, 732-235-2465
- Recruiting
David H Koch, Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Kathryn Arbour, Site 104, 646-608-3792
- Recruiting
Cancer and Hematology Centers of Western Michigan
Norton Shores, Michigan, 49444
Sreenivasa Chandana, Site 131, 269-993-6056
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Cesar Perez Batista, Site 121
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054-4502
Tanios Bekaii-Saab, Site 113, 480-301-8000
- Recruiting
New york cancer and blood specialists - Oncology
Port Jefferson Station, New York, 11776
Richard Zuniga, Site 101, 631751050
- Recruiting
New york cancer and blood specialists - Oncology
Port Jefferson Station, New York, 11776
Richard Zuniga, Site 115
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lei Deng, Site 112, 206-606-4801
- Recruiting
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Kyriakos Papadopoulos, Site 102
- Withdrawn
Local Institution - 134
Seattle, Washington, 98109
- Recruiting
Texas Oncology, P.A. - Oncology
Tyler, Texas, 78503
Donald Richards, Site 110, 903-579-9800
About this study
Official title: 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.
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.
- Conditions
- Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor
- Being tested
- MRTX1719
- 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
- Medical subject headings
- Mesothelioma, Carcinoma, Non-Small-Cell Lung, Neurofibrosarcoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX1719Drug
MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/1B | Experimental | Dose Escalation/Evaluation Receives: Drug: MRTX1719 |
| Phase 1b Sub-studies 1-4 | Experimental | Not described Receives: Drug: MRTX1719 |
| Phase 1b Sub-study 5 | Experimental | Not described Receives: Drug: MRTX1719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who Experience Dose-Limiting Toxicity
Measured: 21 days
Number of patients who experience a treatment-related adverse event
Measured: Up to 2 years
Objective response rate (ORR)
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Progression free survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Number of Patients With Clinically Significant Laboratory Assessments
Measured: Up to 4 years
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Measured: Up to 4 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 4 days
Terminal elimination half-life (t1/2)
Measured: Up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Measured: Up to 4 days
Apparent volume of distribution when dosed orally (Vz/F)
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start9 Jun 2022
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245500
- Sponsor's protocol ID
- CA240-0007
- Other IDs
- CA240-0007, 1719-001
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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