Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Launched by BRISTOL-MYERS SQUIBB · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MRTX1719 for patients with advanced solid tumors that have a specific genetic change known as the homozygous deletion of the MTAP gene. The types of cancers being targeted include mesothelioma, non-small cell lung cancer, and pancreatic cancer, among others. This study aims to understand how safe the treatment is, how well it works, and how the body processes it.

To participate, patients need to be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers with the specific genetic change. They should have cancer that cannot be surgically removed or has spread to other parts of the body. Participants will undergo a biopsy to help assess how the treatment is working. It’s important to note that some people may not qualify if they have undergone certain previous treatments or have specific health issues. If eligible, participants can expect close monitoring and support throughout the trial.

Gender

ALL

Eligibility criteria

• • 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 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.
• • 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.
• • Other protocol-defined Inclusion/Exclusion criteria apply.