RecruitingPhase 1NCT05245500
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Sponsor
Bristol-Myers Squibb
Enrollment
336 participants
Start Date
Jun 9, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
DRUGMRTX1719
MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
Locations(25)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05245500
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