Phase 1 Study of MRTX1719 Drug in Adults With Advanced Solid Tumors Having MTAP Gene Deletion

What this Trial Is About

Researchers are evaluating MRTX1719 in a Phase 1, open-label, multicenter trial involving patients with advanced, unresectable, or metastatic solid tumors that have a homozygous deletion of the MTAP gene. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MRTX1719. This first-in-human trial includes patients with specific solid tumor types such as mesothelioma, non-small cell lung cancer, malignant peripheral nerve sheath tumors, pancreatic adenocarcinoma, and other advanced solid tumors. The study begins with dose exploration and regimen identification for MRTX1719, a potent PRMT5-MTA inhibitor. As suitable dosing plans are found, Phase 1b expansion cohorts may be added to gather more safety data, pharmacokinetic information, and to compare the effects of food and different formulations capsules versus tablets. Treatment is given on specified days according to the determined dose, and multiple experimental sub-studies are included to further assess the drug. Participants will undergo mandatory tumor biopsies at baseline and during the study unless medically unsafe. Researchers will monitor patients for dose-limiting toxicities, treatment-related adverse events, tumor response rates, duration of response, progression-free survival, and overall survival over periods up to 2 years. Laboratory assessments will also be conducted for up to 4 years. The total duration of participation will vary based on treatment response and safety monitoring, with extensive evaluations throughout the trial.

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion