Phase 1 Study of MRTX1719 for Solid Tumors with MTAP Deletion

This is a Phase 1 clinical trial testing a drug called MRTX1719 in people with advanced solid tumors that have a specific genetic change called a homozygous deletion of the MTAP gene. This includes conditions like mesothelioma, non-small cell lung cancer, and pancreatic adenocarcinoma. MRTX1719 is a PRMT5-MTA inhibitor. The main goals are to see how safe MRTX1719 is, what side effects it causes, and if it helps shrink tumors. Researchers will also study how the body handles the drug. You may be able to join if you are at least 18 years old, have an unresectable or metastatic solid tumor with the MTAP gene deletion, and are able to have a tumor biopsy. The trial plans to enroll up to 336 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving MRTX1719. It aims to enroll up to 336 participants.
What's involved
You would receive MRTX1719 on specified days. You would also need to have a tumor biopsy at the start of the study for pharmacodynamic evaluation.
Compensation
Not stated in the trial record.
Follow-up
The study will track treatment-related adverse events for up to 2 years and objective response rate for 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05245500

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~336 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:MRTX1719

At a glance

Recruiting sites
21 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients who Experience Dose-Limiting Toxicity
Measured over 21 days
+6 more outcomes measured
Mesothelioma
Non Small Cell Lung Cancer
Malignant Peripheral Nerve Sheath Tumors
Solid Tumor
Pancreatic Adenocarcinoma
Advanced Solid Tumor
25 sites across 15 states
Texas5
New York4
Colorado2
Florida2
North Carolina2
Arizona1
Illinois1
Massachusetts1
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Eligibility criteria

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.
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.
  • Number of Patients who Experience Dose-Limiting Toxicity21 days
  • Number of patients who experience a treatment-related adverse eventUp to 2 years
  • Objective response rate (ORR)2 years
  • Duration of response (DOR)2 years
  • Progression free survival (PFS)2 years
  • Overall survival (OS)2 years
  • Number of Patients With Clinically Significant Laboratory AssessmentsUp to 4 years