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Solid TumorsPhase 2NCT07492680

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)

A Phase 2 study testing Navlimetostat, Daraxonrasib and Temozolomide in people with Solid Tumors, run by Bristol-Myers Squibb at 58 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Navlimetostat, Daraxonrasib and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
58 sitesin 13 countries
Study dates
27 Jul 2026to 20 May 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

58 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

58 sites in 13 countries

United States16 sites, 16 recruiting

  • Local Institution - 0119

    Ann Arbor, Michigan, 48109-0922

    Site 0119

    Not yet recruiting

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

    Gideon T Dosunmu, Site 0178

    Recruiting

  • Local Institution - 0182

    Aurora, Colorado, 80045

    Site 0182

    Not yet recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Kristen Marrone, Site 0143, 410-502-5140

    Recruiting

  • Local Institution - 0124

    Boston, Massachusetts, 02114

    Site 0124

    Not yet recruiting

  • Local Institution - 0142

    Buffalo, New York, 14263

    Site 0142

    Not yet recruiting

  • Local Institution - 0100

    Durham, North Carolina, 27705

    Site 0100

    Not yet recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Jordi Rodon, Site 0085, 713-338-1507

    Recruiting

  • Local Institution - 0134

    Madison, Wisconsin, 53792

    Site 0134

    Not yet recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Kristen Spencer, Site 0170, 732-235-2465

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Mrinal Gounder, Site 0139, 646-227-2198

    Recruiting

  • Local Institution - 0129

    Rochester, Minnesota, 55905

    Site 0129

    Not yet recruiting

  • Local Institution - 0174

    Rochester, Minnesota, 55905

    Site 0174

    Not yet recruiting

  • Local Institution - 0181

    Rochester, Minnesota, 55905

    Site 0181

    Not yet recruiting

  • Local Institution - 0096

    San Francisco, California, 94158

    Site 0096

    Not yet recruiting

  • Local Institution - 0086

    Seattle, Washington, 98109

    Site 0086

    Not yet recruiting

Other trials in United States

China6 sites, 6 recruiting

  • Local Institution - 0155

    Beijing, Beijing Municipality, 100071

    Site 0155

    Not yet recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Haifeng Yang, Site 0185

    Recruiting

  • Local Institution - 0184

    Guangzhou, Guangdong, 510060

    Site 0184

    Not yet recruiting

  • Shanghai GoBroad Cancer Hospital China Pharmaceutical University

    Shanghai, Shanghai Municipality, 200131

    Jun Zhou, Site 0156, +8613901906998

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Jian Zhang, Site 0153, 18017312991

    Recruiting

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang, Henan, 453100

    Ying-Hua Ji, Site 0152

    Recruiting

Other trials in China

Germany6 sites, 6 recruiting

  • Universitaetsklinikum Hamburg

    Hamburg, 20246

    Joseph Tintelnot, Site 0040

    Recruiting

  • Local Institution - 0039

    Heidelberg, 69120

    Site 0039

    Not yet recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Benjamin Kobitzsch, Site 0061

    Recruiting

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

    Sergio Zapata Bonilla, Site 0081

    Recruiting

  • Klinikum Rechts der Isar der Technischen Universitaet Muenchen

    München, 81675

    Anna Hecht, Site 0049

    Recruiting

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

    Elisabeth Goebeler, Site 0047, 4993120140155

    Recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

    Alberto Zambelli, Site 0123, +390352674366

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Matteo Duca, Site 0034, 00393391639077

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

    Paolo Ascierto, Site 0050, 390815903431

    Recruiting

  • Hospital Santa Maria della Misericordia in Perugia

    Perugia, 06156

    Mario Mandalà, Site 0082, 00393386605619

    Recruiting

  • Azienda Ospedaliero Universitaria Senese

    Siena, Tuscany, 53100

    Michele Maio, Site 0073, 390577586335

    Recruiting

Other trials in Italy

France4 sites, 4 recruiting

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

    francois ghiringhelli, Site 0078, 0380737500

    Recruiting

  • Hôpital Saint-Louis

    Paris, 75010

    Celeste Lebbe, Site 0074, 33142494949

    Recruiting

  • Local Institution - 0075

    Pierre-Bénite, Rhône, 69310

    Site 0075

    Not yet recruiting

  • Local Institution - 0116

    Villejuif, Val-de-Marne, 94800

    Site 0116

    Not yet recruiting

Other trials in France

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Irene Brana Garcia, Site 0068, 34934894158

    Recruiting

  • Local Institution - 0071

    Hospitalet, Barcelona [Barcelona], 08907

    Site 0071

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009

    Ivan Marquez Rodas, Site 0033, 34914269394

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    FATIMA TOSCANO, Site 0069, 955013068

    Recruiting

Other trials in Spain

Belgium3 sites, 3 recruiting

  • UZ Brussel

    Brussels, Bruxelles-Capitale, Région de, 1090

    Bart Neyns, Site 0077, 3224775457

    Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région de, 1200

    Cedric van Marcke de Lummen, Site 0148, 3227644217

    Recruiting

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Celine Jacobs, Site 0114, 3293321071

    Recruiting

Other trials in Belgium

Canada3 sites, 3 recruiting

  • Local Institution - 0021

    Toronto, Ontario, M4N 3M5

    Site 0021

    Not yet recruiting

  • Local Institution - 0007

    Toronto, Ontario, M5G 2M9

    Site 0007

    Not yet recruiting

  • Local Institution - 0051

    Vancouver, British Columbia, V2S 0C2

    Site 0051

    Not yet recruiting

Other trials in Canada

Ireland3 sites, 3 recruiting

  • Cork University Hospital

    Cork, T12 E8YV

    Jack Gleeson, Site 0080, 0863313074

    Recruiting

  • Mater Misericordiae University Hospital (MMUH)

    Dublin, 7

    Austin Duffy, Site 0023, 353018035481

    Recruiting

  • Local Institution - 0146

    Dublin, D08 E9P6

    Site 0146

    Not yet recruiting

Other trials in Ireland

South Korea3 sites, 3 recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

    Do-Youn Oh, Site 0004, 82220720701

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

    Hye Jin Choi, Site 0058, 82222288133

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

    Dae Ho Lee, Site 0052, 82230103214

    Recruiting

Other trials in South Korea

Hong Kong2 sites, 2 recruiting

  • Local Institution - 0150

    Hksar, 999077

    Site 0150

    Not yet recruiting

  • Local Institution - 0063

    Shatin, NT

    Site 0063

    Not yet recruiting

Other trials in Hong Kong

Norway2 sites, 2 recruiting

  • Haukeland Universitetssjukehus

    Bergen, Hordaland, 5021

    Kristine Aasebo, Site 0171, +4755975000

    Recruiting

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 0450

    Tormod Kyrre Guren, Site 0022, 4799024906

    Recruiting

Other trials in Norway

Japan1 site, 1 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Jun Sato, Site 0020, 81335422511

    Recruiting

Other trials in Japan

About this study

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)

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.

Read the detailed description

Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating Navlimetostat (BMS-986504) as monotherapy. Part 2 will include dose-escalation cohorts in which Navlimetostat (BMS-986504) is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.

Conditions
Solid Tumors
Being tested
Navlimetostat, Daraxonrasib, Temozolomide, Pumitamig, Pemetrexed
Keywords
MTAP, CDKN2A, PRMT5, MountainTAP, Targeted therapy, Brain cancer, GBM, Melanoma, NSCLC, Lung cancer, Pancreatic cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Navlimetostat, Navli
Medical subject headings
Brain Neoplasms, Melanoma, Lung Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavlimetostatDrug

    Also called MRTX1719, BMS-986504

    Specified dose on specified days

  • DaraxonrasibDrug

    Also called RMC-6236

    Specified dose on specified days

  • TemozolomideDrug

    Specified dose on specified days

  • PumitamigDrug

    Also called BNT327, BMS-986545

    Specified dose on specified days

  • PemetrexedDrug

    Specified dose on specified days

  • CarboplatinDrug

    Specified dose on specified days

  • Nab-paclitaxelDrug

    Also called Abraxane

    Specified dose on specified days

  • GemcitabineDrug

    Specified dose on specified days

  • PaclitaxelDrug

    Specified dose on specified days

  • CisplatinDrug

    Specified dose on specified days

Study groups in NCT07492680
Study groupRoleWhat they receive
Part 1aExperimentalNavlimetostat (BMS-986504)
Receives: Drug: Navlimetostat
Part 1bExperimentalNavlimetostat (BMS-986504)
Receives: Drug: Navlimetostat
Part 2: Cohort 1ExperimentalNavlimetostat (BMS-986504) + Pumitamig + Chemotherapy
Receives: Drug: Navlimetostat; Drug: Pumitamig; Drug: Pemetrexed; Drug: Carboplatin; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Cisplatin
Part 2: Cohort 2aExperimentalNavlimetostat (BMS-986504) + Daraxonrasib
Receives: Drug: Navlimetostat; Drug: Daraxonrasib
Part 2: Cohort 2bExperimentalNavlimetostat (BMS-986504) + Daraxonrasib
Receives: Drug: Navlimetostat; Drug: Daraxonrasib
Part 2: Cohort 2cExperimentalNavlimetostat (BMS-986504) + Daraxonrasib + Chemotherapy
Receives: Drug: Navlimetostat; Drug: Daraxonrasib; Drug: Nab-paclitaxel; Drug: Gemcitabine
Part 2: Cohort 4ExperimentalNavlimetostat (BMS-986504) + Temozolomide + Radiotherapy
Receives: Drug: Navlimetostat; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of participants who achieve Objective Response (OR)

    OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

    Measured: Up to approximately 2 years

  2. Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria

    Measured: Up to approximately 2 years

  3. Part 2: Number of participants with adverse events (AE)

    Measured: Up to approximately 2 years

  4. Part 2: Number of participants with Serious AEs (SAEs)

    Measured: Up to approximately 2 years

  5. Part 2: Number of participants with treatment related AEs

    Measured: Up to approximately 2 years

  6. Part 2: Number of participants with treatment related SAEs

    Measured: Up to approximately 2 years

  7. Part 2: Number of participants with AEs leading to study treatment discontinuation

    Measured: Up to approximately 2 years

  8. Part 2: Number of participants with AEs leading to death

    Measured: Up to approximately 2 years

  9. Part 2: Number of participants with laboratory abnormalities

    Measured: Up to approximately 2 years

Secondary outcomes (12)

  1. Part 1 and 2: Time to objective response (TTOR)

    Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1

    Measured: Up to approximately 2 years

  2. Part 1 and 2: Duration of response (DOR)

    Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1

    Measured: Up to approximately 2 years

  3. Part 1 and 2: Number of participants who achieve disease control (DC)

    Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1

    Measured: Up to approximately 2 years

  4. Part 1: Number of participants with adverse events (AE)

    Measured: Up to approximately 2 years

  5. Part 1: Number of participants with Serious AEs (SAEs)

    Measured: Up to approximately 2 years

  6. Part 1: Number of participants with treatment related AEs

    Measured: Up to approximately 2 years

  7. Part 1: Number of participants with treatment related SAEs

    Measured: Up to approximately 2 years

  8. Part 1: Number of participants with AEs leading to study treatment discontinuation

    Measured: Up to approximately 2 years

  9. Part 1: Number of participants with AEs leading to death

    Measured: Up to approximately 2 years

  10. Part 1: Number of participants with laboratory abnormalities

    Measured: Up to approximately 2 years

  11. Part 2: Number of participants who achieve Objective Response (OR)

    Measured: Up to approximately 2 years

  12. Part 1 and 2: Number of participants who achieved clinical benefit (CB)

    CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start27 Jul 2026
  3. Primary completion15 Aug 2028 (estimated)
  4. Study completion20 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07492680
Sponsor's protocol ID
CA240-0005
Other IDs
2025-524285-18, U1111-1330-1428, 2025
Status last verified
Nov 2026
First submitted
20 Mar 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Navlimetostat, Daraxonrasib and Temozolomide in people with Solid Tumors, run by Bristol-Myers Squibb at 58 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, China, Germany, Italy, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of participants who achieve Objective Response (OR) (time frame: Up to approximately 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07492680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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