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Trial ID CA240-0007  |   NCT05245500

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

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 21
    Locations
  • BMS Recruiting Study icon
    Recruiting

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA.
    1. Unresectable or metastatic disease.
      1. 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.
        1. Age ≥ 18 years.
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
            1. Adequate organ function.

              Exclusion Criteria

              Exclusion Criteria Icon
              • Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
                1. Active brain metastases or carcinomatous meningitis.
                  1. History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
                    1. Major surgery within 4 weeks of first dose of study treatment.
                      1. 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.
                        1. Cardiac abnormalities.
                          Additional Information *
                          • Other protocol-defined Inclusion/Exclusion criteria apply.

                            Treatment Options

                            Study Arms

                            ASSIGNED INTERVENTION

                            Study Arms

                            Experimental: Phase 1/1B

                            ASSIGNED INTERVENTION
                            • Drug: MRTX1719

                            Study Arms

                            Experimental: Phase 1b Sub-Study

                            ASSIGNED INTERVENTION
                            • Drug: MRTX1719

                            Study Arms

                            Experimental: Phase 2

                            ASSIGNED INTERVENTION
                            • Drug: MRTX1719
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