Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05245500

Patient View

This Phase 1/2 open-label study evaluates MRTX1719, a PRMT5-MTA inhibitor, in patients with advanced solid tumors and MTAP deletion. It explores dosing, safety, PK, and PD, with Phase 1b focusing on regimen optimization and Phase 2 assessing clinical efficacy across patient cohorts. MRTX1719 is administered in specified doses on designated days.

Patient Parameters

Program Overview

This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.

Description

This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1719.

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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