A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Bristol-Myers Squibb
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.
Description
This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 carcino…
Interventions
- DrugMRTX1719
MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
Locations (25)
- Mayo ClinicPhoenix, Arizona
- Sarah Cannon Research Institute (SCRI) - HealthONE LocationDenver, Colorado
- Rocky Mountain Cancer Centers, LLP - OncologyLone Tree, Colorado
- Mayo ClinicJacksonville, Florida
- Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, Florida
- Local Institution - 124Chicago, Illinois