← Back to searchRecruitingRecruiting
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
NCT05245500 · Bristol-Myers Squibb
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
About this study
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.
Eligibility criteria
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 target: 336 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-06-09
Estimated completion: 2027-12-10
Last updated: 2025-12-05
Interventions
Drug: MRTX1719
Primary outcomes
- • Number of Patients who Experience Dose-Limiting Toxicity (21 days)
- • Number of patients who experience a treatment-related adverse event (Up to 2 years)
- • Objective response rate (ORR) (2 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain the NCT# and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (25)
Mayo ClinicRecruiting
Phoenix, Arizona, United States
Sarah Cannon Research Institute (SCRI) - HealthONE LocationRecruiting
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP - OncologyRecruiting
Lone Tree, Colorado, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
Orlando, Florida, United States
Local Institution - 124Withdrawn
Chicago, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Brookline, Massachusetts, United States
Cancer and Hematology Centers of Western MichiganRecruiting
Norton Shores, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Local Institution - 129Not Yet Recruiting
Mineola, New York, United States
David H Koch, Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
New york cancer and blood specialists - OncologyRecruiting
Port Jefferson Station, New York, United States
New york cancer and blood specialists - OncologyRecruiting
Port Jefferson Station, New York, United States
University of North Carolina - Gastroenterology and HepatologyRecruiting
Chapel Hill, North Carolina, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Vanderbilt - Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
Ut SouthwesternRecruiting
Dallas, Texas, United States
Texas Oncology - DFWRecruiting
Fort Worth, Texas, United States
MDACCRecruiting
Houston, Texas, United States
South Texas Accelerated Research TherapeuticsRecruiting
San Antonio, Texas, United States
Texas Oncology, P.A. - OncologyRecruiting
Tyler, Texas, United States
Virginia Cancer Specialists, PCRecruiting
Fairfax, Virginia, United States
Local Institution - 134Withdrawn
Seattle, Washington, United States
Local Institution - 108Completed
Milwaukee, Wisconsin, United States