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Trial ID CA240-0009  |   NCT06855771

A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9)

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 39
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy or in combination with Izalontamab Brengitecan in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion or MTAP loss after progression on prior therapies.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
    1. Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
      1. At least 1 measurable lesion as per RECIST v1.1.
        1. Documented radiographic disease progression on or after the most recent line of treatment.
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
            1. Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
              1. Capability to swallow tablets intact (without chewing or crushing).
                1. For combination arms 1. Participants must have documented evidence of EGFR status. 2. Participants with EGFR mutant or wild type NSCLC are allowed.

                  Exclusion Criteria

                  Exclusion Criteria Icon
                  • Active brain metastases or carcinomatous meningitis.
                    1. 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. Prior treatment with a PRMT5 or MAT2A inhibitor.
                        1. Known severe hypersensitivity to study treatment and/or any of its excipients.
                          1. For combination arms a. Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab.
                            1. Other protocol-defined inclusion/exclusion criteria apply.
                              Additional Information *

                              Treatment Options

                              Study Arms

                              ASSIGNED INTERVENTION

                              Study Arms

                              Experimental: Arm A: BMS-986504 Dose 1

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986504

                              Study Arms

                              Experimental: Arm B: BMS-986504 Dose 2

                              ASSIGNED INTERVENTION
                              • Drug: BMS-986504

                              Study Arms

                              Experimental: Arm C: BMS-986504 Dose 1 + Izalontamab Brengitecan

                              ASSIGNED INTERVENTION
                              • Drug: Izalontamab Brengitecan, BMS-986504

                              Study Arms

                              Experimental: Arm D: BMS-986504 Dose 2 + Izalontamab Brengitecan

                              ASSIGNED INTERVENTION
                              • Drug: Izalontamab Brengitecan, BMS-986504
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