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)

NCT06855771 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2025-09-09

Last updated

2026-09-18

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

BMS-986504Izalontamab Brengitecan

BMS-986504: Specified dose on specified days

Izalontamab Brengitecan: Specified dose on specified days

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — Up to 3 years after the last participant's last dose of study treatment
OR is defined as confirmed complete response (CR) or partial response (PR)
Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with adverse events (AE) — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with Serious AEs (SAEs) — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with treatment related AEs — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with treatment related SAEs — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with AEs leading to study treatment discontinuation — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with AEs leading to death — Up to 28 days after the last dose of study treatment
Arm C and Arm D
Number of participants with laboratory abnormalities — Up to 28 days after the last dose of study treatment
Arm C and Arm D

Trial sites (67)

Facility	City	Region	Status
Local Institution - 0088	Anchorage	Alaska	Completed
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Washington University School of Medicine	St Louis	Missouri	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Gabrail Cancer Center	Canton	Ohio	Recruiting
Providence Portland Medical Center	Portland	Oregon	Recruiting
Oregon Health and Science University	Portland	Oregon	Recruiting
Fred Hutchison Cancer Center	Seattle	Washington	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting
GenesisCare - Campbelltown	Campbelltown	New South Wales	Recruiting
Chris O'Brien Lifehouse	Camperdown	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting
Local Institution - 0097	Adelaide	South Australia	Completed
Beijing Chest Hospital,Capital Medical University	Beijing	Beijing Municipality	Recruiting
The First Affiliated hospital of Xiamen University	Xiamen	Fujian	Recruiting
Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi	Recruiting
The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
Shandong Cancer Hospital	Jinan	Shandong	Recruiting
LinYi Cancer Hospital	Linyi	Shandong	Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang	Recruiting
Chu Grenoble Alpes	La Tronche	Isère	Recruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes	Saint-Herblain	Loire-Atlantique	Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel	Bron	Rhône	Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin	Paris	France	Recruiting
Institut Curie	Paris	France	Recruiting
Hôpital Tenon	Paris	France	Recruiting
Groupe hospitalier Paris saint Joseph	Paris	Île-de-France Region	Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen	München	Bavaria	Recruiting
Universitätsklinikum Frankfurt Goethe-Universität	Frankfurt am Main	Hesse	Recruiting
Krankenhaus Martha-Maria Halle-Dölau	Halle	Saxony-Anhalt	Recruiting
Universitaetsklinikum Koeln	Cologne	Germany	Recruiting
Universitaetsklinikum Wuerzburg	Würzburg	Germany	Recruiting
AOU della Campania Luigi Vanvitelli	Naples	Campania	Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale	Naples	Campania	Recruiting
Fondazione IRCCS San Gerardo dei Tintori	Monza	Lombardy	Recruiting
ASST Grande Ospedale Metropolitano Niguarda	Milan	Milano	Recruiting
Istituto Oncologico Veneto IRCCS	Padova	Veneto	Recruiting

+ 27 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855771 on ClinicalTrials.gov ↗ ← All trials in the USA