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ID del estudio CA236-0001  |   NCT06697197

A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 1/Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 6
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
    1. Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
      1. Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).
        1. Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should have documented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skipping mutations, and BRAF V600E.Participants must have received platinum-based chemotherapy and anti-PD-(L)1 therapy, if eligible and available.
          1. Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, or unknown primary melanoma. Participants with uveal/ocular melanoma are excluded. Participants must be melanoma 2L+.
            1. Participants in Part 1B3 must have advanced or metastatic MSS-CRC.
              1. Participants in Part 2A may have advanced solid tumors (advanced, unresectable, or metastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer or pancreatic adenocarcinoma [PDAC]) based on emerging data.
                1. Participants in Part 2B3 must have advanced or metastatic MSS-CRC.
                  1. For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy [core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen] must be obtained (obtained within 1 month of the start of the Screening, if there are tumor sites that can be biopsied with acceptable clinical risk).

                    Criterios de exclusión

                    Criterios de exclusión Icon
                    :
                    • History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
                      1. Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
                        Información Adicional *
                        • Other protocol-defined Inclusion/Exclusion criteria apply.

                          Opciones de tratamiento

                          Brazos del estudio

                          INTERVENCIÓN ASIGNADA

                          Brazos del estudio

                          Experimental: Part 1A

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482

                          Brazos del estudio

                          Experimental: Part 1B1

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Nivolumab and rHuPH20

                          Brazos del estudio

                          Experimental: Part 1B2

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Nivolumab/relatlimab/rHuPH20

                          Brazos del estudio

                          Experimental: Part 1B3

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Bevacizumab

                          Brazos del estudio

                          Experimental: Part 1C

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482

                          Brazos del estudio

                          Experimental: Part 2A

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482

                          Brazos del estudio

                          Experimental: Part 2B1

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Nivolumab and rHuPH20

                          Brazos del estudio

                          Experimental: Part 2B2

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Nivolumab/relatlimab/rHuPH20

                          Brazos del estudio

                          Experimental: Part 2B3

                          INTERVENCIÓN ASIGNADA
                          • Drug: BMS-986482, Bevacizumab
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