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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CA243-0001  |   NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Resumen

  • Phase 1
  • Ícono de género masculino y femenino
  • 18+
  • 13
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Participants must be ≥ 18 years of age.
    1. Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
      1. Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
        1. Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
          1. For Part 2A only, participants must have CCNE1-amplified ovarian cancer

            Criterios de exclusión

            Criterios de exclusión Icon
            :
            • Participants must not have an active brain metastasis.
              1. Participants must not have impaired cardiac function or clinically significant cardiac disease.
                1. Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
                  1. Participants must not have Grade ≥ 2 peripheral neuropathy.
                    Información Adicional *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Opciones de tratamiento

                      Brazos del estudio

                      INTERVENCIÓN ASIGNADA

                      Brazos del estudio

                      Experimental: Part 1A Monotherapy Dose Escalation

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986500

                      Brazos del estudio

                      Experimental: Part 1B Combination Dose Escalation

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986500, Palbociclib, Fulvestrant

                      Brazos del estudio

                      Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986500

                      Brazos del estudio

                      Experimental: Part 2A Monotherapy Dose Expansion

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986500

                      Brazos del estudio

                      Experimental: Part 2B Combination Dose Expansion

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986500, Palbociclib, Fulvestrant
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