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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 days
Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Number of Patients With Clinically Significant Laboratory Assessments
Time frame: Up to 4 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Time frame: Up to 4 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 4 days
Terminal elimination half-life (t1/2)
Time frame: Up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Time frame: Up to 4 days
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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CONTACT
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RECRUITING...and 15 more locations
Apparent volume of distribution when dosed orally (Vz/F)
Time frame: Up to 4 days