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ID del estudio CA242-0001  |   NCT07195682

A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 1
  • Ícono de género masculino y femenino
  • 18+
  • 8
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
    1. For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
      1. For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
        1. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          Criterios de exclusión

          Criterios de exclusión Icon
          :
          • Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
            1. For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
              1. Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
                1. Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
                  Información Adicional *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Opciones de tratamiento

                    Brazos del estudio

                    INTERVENCIÓN ASIGNADA

                    Brazos del estudio

                    Experimental: BMS-986506: Part 1A

                    INTERVENCIÓN ASIGNADA
                    • Drug: BMS-986506

                    Brazos del estudio

                    Experimental: BMS-986506: Part 2A

                    INTERVENCIÓN ASIGNADA
                    • Drug: BMS-986506

                    Brazos del estudio

                    Experimental: BMS-986506: Part 2B

                    INTERVENCIÓN ASIGNADA
                    • Drug: BMS-986506
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