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ID del estudio CA240-0005  |   NCT07492680

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

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Lo sentimos, este estudio aún no acepta participantes.
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Resumen

  • Phase 2
  • Ícono de género masculino y femenino
  • 18+
  • 38
  • Ícono de BMS, estudio No reclutando aún
    Not Yet Recruiting

Descripción general

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
    1. Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
      1. Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
        1. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer should be ≤ 2 × ULN.
          1. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

            Criterios de exclusión

            Criterios de exclusión Icon
            :
            • Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
              1. Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
                1. Participants must not have history of gastrointestinal disease 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.
                  1. Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
                    1. Participants must not have active viral HBV or HCV hepatitis. Other protocol defined inclusion/exclusion criteria applies.
                      Información Adicional *

                      Opciones de tratamiento

                      Brazos del estudio

                      INTERVENCIÓN ASIGNADA

                      Brazos del estudio

                      Experimental: Part 1a

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504

                      Brazos del estudio

                      Experimental: Part 1b

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504

                      Brazos del estudio

                      Experimental: Part 2: Cohort 1

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Pumitamig, Pemetrexed, Carboplatin, Nab-paclitaxel, Paclitaxel

                      Brazos del estudio

                      Experimental: Part 2: Cohort 2a

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Daraxonrasib

                      Brazos del estudio

                      Experimental: Part 2: Cohort 2b

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Daraxonrasib

                      Brazos del estudio

                      Experimental: Part 2: Cohort 2c

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Daraxonrasib, Nab-paclitaxel, Gemcitabine

                      Brazos del estudio

                      Experimental: Part 2: Cohort 3

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Nivolumab + Relatlimab FDC

                      Brazos del estudio

                      Experimental: Part 2: Cohort 4

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986504, Temozolomide
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