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Trial ID CA240-0005  |   NCT07492680

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

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 38
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (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 Navlimetostat (BMS-986504) is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Navlimetostat (BMS-986504) alone and in combination regimens.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss 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 and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline.
        1. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer.
          1. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

            Exclusion Criteria

            Exclusion Criteria 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 within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) 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.
                      1. Other protocol defined inclusion/exclusion criteria applies.
                        Additional Information *

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Part 1a

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat

                        Study Arms

                        Experimental: Part 1b

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat

                        Study Arms

                        Experimental: Part 2: Cohort 1

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat, Pemetrexed, Carboplatin, Nab-paclitaxel, Cisplatin, Pumitamig, Paclitaxel

                        Study Arms

                        Experimental: Part 2: Cohort 2a

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat, Daraxonrasib

                        Study Arms

                        Experimental: Part 2: Cohort 2b

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat, Daraxonrasib

                        Study Arms

                        Experimental: Part 2: Cohort 2c

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat, Daraxonrasib, Gemcitabine, Nab-paclitaxel

                        Study Arms

                        Experimental: Part 2: Cohort 4

                        ASSIGNED INTERVENTION
                        • Drug: Navlimetostat, Temozolomide
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