Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
About this study
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.
- Condition
- Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor
- Tested
- MRTX1719
- Sponsor
- Bristol-Myers Squibb
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor
- 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 7
- 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
25 sites, 22 recruiting
Dana-Farber Cancer Institute
Brookline, Massachusetts, United States
University of North Carolina - Gastroenterology and Hepatology
Chapel Hill, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Ut Southwestern
Dallas, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Texas Oncology - DFW
Fort Worth, Texas, United States
and 19 more sites on ClinicalTrials.gov
Contact
-
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286 Clinical.Trials@bms.com
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First line of the email MUST contain NCT # and Site #.
Potential match only. Final eligibility is determined by the study team.