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ID del estudio CA240-0007  |   NCT05245500

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

Resumen

  • Phase 1/Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 21
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

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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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • 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. Patients must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment. 1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease 2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable 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

                Criterios de exclusión

                Criterios de exclusión 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
                            Información Adicional *

                            Opciones de tratamiento

                            Brazos del estudio

                            INTERVENCIÓN ASIGNADA

                            Brazos del estudio

                            Experimental: Phase 1/1B

                            INTERVENCIÓN ASIGNADA
                            • Drug: MRTX1719

                            Brazos del estudio

                            Experimental: Phase 1b Sub-Study

                            INTERVENCIÓN ASIGNADA
                            • Drug: MRTX1719

                            Brazos del estudio

                            Experimental: Phase 2

                            INTERVENCIÓN ASIGNADA
                            • Drug: MRTX1719
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