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.
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.
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.
Sequential
MRTX1719
DrugMRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days
Number of Patients who Experience Dose-Limiting Toxicity
Number of patients who experience a treatment-related adverse event
Objective response rate (ORR)
Duration of response (DOR)
Area under the plasma concentration versus time curve (AUC)
Time to achieve maximal plasma concentration (Tmax)
Maximum observed plasma concentration (Cmax)
Terminal elimination half-life (t1/2)
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