Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

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.

Interventions

• MRTX1719 · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (25)

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• Local Institution - 124, Chicago, Illinois · WITHDRAWN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• Local Institution - 134, Seattle, Washington · WITHDRAWN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