Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Recruiting now · Phase 1

Conditions studied: Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05245500

Run by

Bristol-Myers Squibb

People needed

336

Starts

2022-06-09

Expected to finish

2027-12-10

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Mayo Clinic — Phoenix, Arizona, United States (enrolling)
• Sarah Cannon Research Institute (SCRI) - HealthONE Location — Denver, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP - Oncology — Lone Tree, Colorado, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States (enrolling)
• MDACC — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (enrolling)
• Texas Oncology, P.A. - Oncology — Tyler, Texas, United States (enrolling)
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (enrolling)
• Dana-Farber Cancer Institute — Brookline, Massachusetts, United States (enrolling)
• Cancer and Hematology Centers of Western Michigan — Norton Shores, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• David H Koch, Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• New york cancer and blood specialists - Oncology — Port Jefferson Station, New York, United States (enrolling)
• New york cancer and blood specialists - Oncology — Port Jefferson Station, New York, United States (enrolling)
• University of North Carolina - Gastroenterology and Hepatology — Chapel Hill, North Carolina, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• Ut Southwestern — Dallas, Texas, United States (enrolling)
• Texas Oncology - DFW — Fort Worth, Texas, United States (enrolling)
• Local Institution - 124 — Chicago, Illinois, United States
• Local Institution - 108 — Milwaukee, Wisconsin, United States
• Local Institution - 129 — Mineola, New York, United States
• Local Institution - 134 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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