Testing MRTX1719 for solid tumors with MTAP deletion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of MRTX1719 in patients with advanced solid tumors that have a homozygous deletion of the MTAP gene. The study begins with dose exploration and may expand into additional cohorts to gather more safety data and early evidence of clinical activity. Participants will undergo mandatory biopsies for pharmacodynamic evaluation unless deemed unsafe. The trial is open-label and multicenter, involving several prominent cancer treatment facilities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• Rocky Mountain Cancer Centers, LLP - Oncology
  Lone Tree, Colorado, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Sarah Cannon Research Institute at Florida Cancer Specialists
  Orlando, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Brookline, Massachusetts, United States Recruiting
• The Cancer & Hematology Centers
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.