Tests MRTX1719 in advanced solid tumors with a specific MTAP gene deletion

Trial details

Who runs it

Bristol-Myers Squibb

Trial code

NCT05245500

Record updated

2 September 2026

Original description

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.Read full original descriptionShow less

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

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.

Inclusion: 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: Prior treatment with a PRMT5 or MAT2A inhibitor therapy; Major surgery within 4 weeks of first dose of study treatment; History of significant hemoptysis or hemorrhage within 4 weeks of the 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; Active brain metastases or carcinomatous meningitis; Other protocol-defined Inclusion/Exclusion criteria apply.

ClinicalTrials.gov NCT05245500