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RECRUITING

NCT07492680

PHASE2

A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which Navlimetostat (BMS-986504) is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Navlimetostat (BMS-986504) alone and in combination regimens.

Official title: A Phase 2 Open-Label, Multi-Center Study of Navlimetostat (BMS-986504) as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTap-5)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

254

Start Date

2026-07-27

Completion Date

2032-05-20

Last Updated

2026-11-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Navlimetostat

Specified dose on specified days

DRUG

Daraxonrasib

Specified dose on specified days

DRUG

Temozolomide

Specified dose on specified days

DRUG

Pumitamig

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Nab-paclitaxel

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

DRUG

Paclitaxel

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease. * Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have inadequate organ function, as determined by laboratory testing within the screening period. * Participants must not have active viral HBV or HCV hepatitis. * Other protocol defined inclusion/exclusion criteria applies.

Locations (58)

Local Institution - 0096

San Francisco, California, United States

Local Institution - 0182

Aurora, Colorado, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Local Institution - 0124

Boston, Massachusetts, United States

Local Institution - 0119

Ann Arbor, Michigan, United States

Local Institution - 0129

Rochester, Minnesota, United States

Local Institution - 0174

Rochester, Minnesota, United States

Local Institution - 0181

Rochester, Minnesota, United States

Local Institution - 0142

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 0100

Durham, North Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Local Institution - 0086

Seattle, Washington, United States

Local Institution - 0134

Madison, Wisconsin, United States

UZ Brussel

Brussels, Bruxelles-Capitale, Région de, Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0051

Vancouver, British Columbia, Canada

Local Institution - 0021

Toronto, Ontario, Canada

Local Institution - 0007

Toronto, Ontario, Canada

Local Institution - 0155

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Local Institution - 0184

Guangzhou, Guangdong, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Local Institution - 0075

Pierre-Bénite, Rhône, France

Local Institution - 0116

Villejuif, Val-de-Marne, France

Hôpital Saint-Louis

Paris, France

Local Institution - 0081

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Hamburg

Hamburg, Germany

Local Institution - 0039

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Klinikum Rechts der Isar der Technischen Universitaet Muenchen

München, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Local Institution - 0150

Hksar, Hong Kong

Local Institution - 0063

Shatin, Hong Kong

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital (MMUH)

Dublin, Ireland

Local Institution - 0146

Dublin, Ireland

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy

Hospital Santa Maria della Misericordia in Perugia

Perugia, Italy

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Haukeland Universitetssjukehus

Bergen, Hordaland, Norway

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0071

Hospitalet, Barcelona [Barcelona], Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain