Trial NCT05245500
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
- Phase
- Phase 1
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Mesothelioma; Non Small Cell Lung Cancer; Malignant Peripheral Nerve Sheath Tumors; Solid Tumor; Pancreatic Adenocarcinoma; Advanced Solid Tumor
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* Adequate organ function.
Exclusion Criteria
* Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
* Active brain metastases or carcinomatous meningitis.Brain metastases
* 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.
Restrictions found (2)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Brookline, Norfolk County