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  • NCT06997029

Not Yet Recruiting

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors - CA243-0001

Actualizada: 21 mayo, 2025   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 13

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part 1A Monotherapy Dose Escalation
Drug: BMS-986500
Experimental: Part 1B Combination Dose Escalation
Drug: BMS-986500, Palbociclib, Fulvestrant
Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
Drug: BMS-986500
Experimental: Part 2A Monotherapy Dose Expansion
Drug: BMS-986500
Experimental: Part 2B Combination Dose Expansion
Drug: BMS-986500, Palbociclib, Fulvestrant

Criterios clave de elegibilidad

Inclusion Criteria: - Participants must be ≥ 18 years of age. - Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. - Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1. - For Part 2A only, participants must have CCNE1-amplified ovarian cancer Exclusion Criteria: - Participants must not have an active brain metastasis. - Participants must not have impaired cardiac function or clinically significant cardiac disease. - Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. - Participants must not have Grade ≥ 2 peripheral neuropathy. - Other protocol-defined Inclusion/Exclusion criteria apply.

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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