Testing MRTX1719 for solid tumors with MTAP deletion
A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
PHASE1 · Bristol-Myers Squibb · NCT05245500
This study is testing a new drug called MRTX1719 to see if it can help people with advanced solid tumors that have a specific gene deletion.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 25 sites (Phoenix, Arizona and 24 other locations) |
| Trial ID | NCT05245500 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MRTX1719 in patients with advanced solid tumors that have a homozygous deletion of the MTAP gene. The study begins with dose exploration and may expand into additional cohorts to gather more safety data and early evidence of clinical activity. Participants will undergo mandatory biopsies for pharmacodynamic evaluation unless deemed unsafe. The trial is open-label and multicenter, involving several prominent cancer treatment facilities.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic solid tumors that have a confirmed homozygous deletion of the MTAP gene.
Not a fit: Patients with active brain metastases, prior treatment with specific inhibitors, or significant gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with specific solid tumors that have limited treatment alternatives.
How similar studies have performed: While this approach is novel in targeting MTAP deletion, similar studies have shown promise in treating specific genetic alterations in solid tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 24 other locations
- Mayo Clinic — Phoenix, Arizona, United States (RECRUITING)
- Sarah Cannon Research Institute (SCRI) - HealthONE Location — Denver, Colorado, United States (RECRUITING)
- Rocky Mountain Cancer Centers, LLP - Oncology — Lone Tree, Colorado, United States (RECRUITING)
- Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
- Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States (RECRUITING)
- Local Institution - 124 — Chicago, Illinois, United States (WITHDRAWN)
- Dana-Farber Cancer Institute — Brookline, Massachusetts, United States (RECRUITING)
- Cancer and Hematology Centers of Western Michigan — Norton Shores, Michigan, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (RECRUITING)
- Local Institution - 129 — Mineola, New York, United States (NOT_YET_RECRUITING)
- David H Koch, Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- New york cancer and blood specialists - Oncology — Port Jefferson Station, New York, United States (RECRUITING)
- New york cancer and blood specialists - Oncology — Port Jefferson Station, New York, United States (RECRUITING)
- University of North Carolina - Gastroenterology and Hepatology — Chapel Hill, North Carolina, United States (RECRUITING)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States (RECRUITING)
- Ut Southwestern — Dallas, Texas, United States (RECRUITING)
- Texas Oncology - DFW — Fort Worth, Texas, United States (RECRUITING)
- MDACC — Houston, Texas, United States (RECRUITING)
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (RECRUITING)
- Texas Oncology, P.A. - Oncology — Tyler, Texas, United States (RECRUITING)
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (RECRUITING)
- Local Institution - 134 — Seattle, Washington, United States (WITHDRAWN)
- Local Institution - 108 — Milwaukee, Wisconsin, United States (COMPLETED)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor, MTAP Deletion, MTAP