Phase 1/2 Study of MRTX1719 for Solid Tumors with MTAP Gene Deletion

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05245500

Provider View

This clinical trial is testing a new drug, MRTX1719, to see if it is safe and effective for treating advanced solid tumors that cannot be removed by surgery and have a specific genetic deletion called MTAP.

Patient Parameters

Program Overview

The study is in its early stages and aims to find out if MRTX1719 is safe and how well it works in patients with advanced solid tumors that have a specific genetic deletion known as MTAP. The trial will take place at multiple centers and will involve patients whose tumors cannot be surgically removed or have spread to other parts of the body.

Description

This is the first time MRTX1719 is being tested in humans. The trial will start by exploring different doses and schedules of the drug to find the most effective and safe way to use it. As the study progresses, researchers will look at how the drug is absorbed in the body, how it interacts with food, and whether there is a difference between taking it in capsule or tablet form. If the initial phase shows promising results, the study will expand to include more patients to gather more information on safety and effectiveness. In the second phase, the study will focus on different groups of patients based on their type of cancer and other characteristics to see how well MRTX1719 works for them.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA.
  • 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.

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