Recruiting
Phase 2

BMS-986504

Sponsor:

Bristol-Myers Squibb

Code:

NCT06855771

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986504

Izalontamab Brengitecan

Study Details

Brief summary:

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT06855771

Start date

Sep 9, 2025

Status verified date

Sep, 2026

Completion date

Dec 30, 2031

Anticipated

Primary completion date

Dec 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).
  • 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

  • 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.
  • 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.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: BMS-986504 Dose 1

experimental: Arm B: BMS-986504 Dose 2

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

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

Interventions

BMS-986504

Specified dose on specified days

Izalontamab Brengitecan

Specified dose on specified days

Primary outcome measure

  • Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 3 years after the last participant's last dose of study treatment ]
  • Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with adverse events (AE) [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with Serious AEs (SAEs) [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with treatment related AEs [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with treatment related SAEs [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with AEs leading to study treatment discontinuation [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with AEs leading to death [ Time Frame: Up to 28 days after the last dose of study treatment ]
  • Number of participants with laboratory abnormalities [ Time Frame: Up to 28 days after the last dose of study treatment ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Pasi Janne, Site 0090

617-632-6036

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Hirva Mamdani, Site 0100

909-525-0093

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Anjali Rohatgi, Site 0104

314-747-1171

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kathryn Arbour, Site 0018

646-608-3792

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Nashat Gabrail, Site 0091

330-417-8231

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Rachel Sanborn, Site 0098

503-215-5696

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jeremy Cetnar, Site 0103

503-494-3840

Fred Hutchison Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Lei Deng, Site 0078

206-606-4801

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Jonathan Thompson, Site 0084

414-805-4600

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.