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

Alaska Oncology and Hematology
Anchorage 5879400, Alaska 5879092 99508
Contact:
Steven Liu, Site 0088
907-257-9851

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Pasi Janne, Site 0090
617-632-6036

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Contact:
Dipesh Uprety, Site 0100
215-285-2261

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Kathryn Arbour, Site 0018
646-608-3792

Gabrail Cancer Center
Canton 5149222, Ohio 5165418 44718
Contact:
Nashat Gabrail, Site 0091
330-417-8231

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Rachel Sanborn, Site 0098
503-215-5696

Fred Hutchison Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
Lei Deng, Site 0078
206-606-4801

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com