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ID del estudio CA247-0004  |   NCT05578092

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

Resumen

  • Phase 1/Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 10
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test: 1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation; 2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
    1. Unresectable or metastatic disease
      1. No available treatment with curative intent; standard treatment is not available or patient declines
        1. Presence of tumor lesions to be evaluated per RECIST 1.1: 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
              1. Adequate organ function

                Criterios de exclusión

                Criterios de exclusión Icon
                :
                • Active brain metastases or carcinomatous meningitis
                  1. Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only)
                    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 pneumonitis or interstitial lung disease
                          1. Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors
                            1. Cardiac abnormalities
                              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
                                Información Adicional *

                                Opciones de tratamiento

                                Brazos del estudio

                                INTERVENCIÓN ASIGNADA

                                Brazos del estudio

                                Experimental: Phase 1/1B Combination Therapy

                                INTERVENCIÓN ASIGNADA
                                • Drug: MRTX0902, MRTX849

                                Brazos del estudio

                                Experimental: Phase 1/1B Monotherapy

                                INTERVENCIÓN ASIGNADA
                                • Drug: MRTX0902

                                Brazos del estudio

                                Experimental: Phase 2

                                INTERVENCIÓN ASIGNADA
                                • Drug: MRTX0902, MRTX849
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