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

Purpose

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

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. - 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). - At least 1 measurable lesion as per RECIST v1.1. - Documented radiographic disease progression on or after the most recent line of treatment. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - 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. - Capability to swallow tablets intact (without chewing or crushing).

Exclusion Criteria

  • Active brain metastases or carcinomatous meningitis. - 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. - Prior treatment with a PRMT5 or MAT2A inhibitor. - Known severe hypersensitivity to study treatment and/or any of its excipients. - Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BMS-986504 Dose 1
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719
Experimental
Arm B: BMS-986504 Dose 2
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Anjali Rohatgi, Site 0104
314-747-1171

More Details

NCT ID
NCT06855771
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com