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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CA246-0005  |   NCT05737706

Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

Resumen

  • Phase 1/Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 14
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
    1. Unresectable or metastatic disease.
      1. Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
        1. Presence of tumor lesions to be evaluated per RECIST v1.1: 1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
            1. Adequate organ function.
              1. Age ≥ 18 years

                Criterios de exclusión

                Criterios de exclusión Icon
                :
                • Active brain metastases or carcinomatous meningitis.
                  1. Prior treatment with a KRAS G12D inhibitor (Phase 1b & Phase 2 only).
                    1. History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
                      1. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
                        1. History of malignant small bowel obstruction.
                          1. Cardiac abnormalities.
                            Información Adicional *

                            Opciones de tratamiento

                            Brazos del estudio

                            INTERVENCIÓN ASIGNADA

                            Brazos del estudio

                            Experimental: Phase 1/1B

                            INTERVENCIÓN ASIGNADA
                            • Drug: MRTX1133

                            Brazos del estudio

                            Experimental: Phase 2

                            INTERVENCIÓN ASIGNADA
                            • Drug: MRTX1133
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