Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Launched by BRISTOL-MYERS SQUIBB · Feb 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MRTX1719 for patients with certain types of advanced solid tumors that have a specific genetic change called homozygous deletion of the MTAP gene. These tumors may include mesothelioma, non-small cell lung cancer, pancreatic adenocarcinoma, and others that cannot be surgically removed or have spread to other parts of the body. The main goals of the study are to find out how safe the treatment is, how well it works, and how the body processes it.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of a solid tumor with the specific MTAP gene change. They should also have a tumor that can be biopsied, meaning a small piece of the tumor can be taken for testing. Participants will receive the study treatment and will be closely monitored to see how well it works and if there are any side effects. It’s important to note that some people may not be eligible, such as those who have had certain previous treatments or specific health issues. This trial is currently recruiting participants, and it’s a promising opportunity for those seeking new treatment options for their advanced solid tumors.

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.