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

August 24, 2026 updated by: Bristol-Myers Squibb

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

This is an open-label, multicenter Phase 2 study evaluating 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 BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Belgium
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
        • Not yet recruiting
        • Local Institution - 0148
        • Contact:
          • Site 0148
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Not yet recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V2S 0C2
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • Not yet recruiting
        • Local Institution - 0155
        • Contact:
          • Site 0155
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
    • Henan
      • Xinxiang, Henan, China, 453100
        • Not yet recruiting
        • Local Institution - 0152
        • Contact:
          • Site 0152
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Jian Zhang, Site 0153
          • Phone Number: 18017312991
      • Shanghai, Shanghai Municipality, China, 200131
        • Recruiting
        • Shanghai GoBroad Cancer Hospital China Pharmaceutical University
        • Contact:
          • Jun Zhou, Site 0156
          • Phone Number: +8613901906998
  • France
      • Paris, France, 75010
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
  • Germany
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Heidelberg, Germany, 69120
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
      • München, Germany, 81675
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Würzburg, Germany, 97080
        • Not yet recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
  • Hong Kong
      • Hksar, Hong Kong, 999077
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Shatin, Hong Kong, NT
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
  • Ireland
      • Cork, Ireland, T12 E8YV
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • Dublin, Ireland, 7
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
      • Dublin, Ireland, D08 E9P6
        • Not yet recruiting
        • Local Institution - 0146
        • Contact:
          • Site 0146
  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Naples, Italy, 80131
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Perugia, Italy, 06156
        • Not yet recruiting
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
  • Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • Jun Sato, Site 0020
          • Phone Number: 81335422511
  • Norway
      • Oslo, Norway, 0450
        • Not yet recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Not yet recruiting
        • Local Institution - 0171
        • Contact:
          • Site 0171
  • South Korea
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Dae Ho Lee, Site 0052
          • Phone Number: 82230103214
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Not yet recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
  • Spain
      • Madrid, Spain, 28028
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
      • Seville, Spain, 41013
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Hospitalet, Barcelona [Barcelona], Spain, 08907
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
  • United States
    • California
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Local Institution - 0178
        • Contact:
          • Site 0178
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Kristen Marrone, Site 0143
          • Phone Number: 410-502-5140
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Local Institution - 0142
        • Contact:
          • Site 0142
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Local Institution - 0170
        • Contact:
          • Site 0170
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Local Institution - 0139
        • Contact:
          • Site 0139
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene 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.
  • Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 2: Cohort 1
BMS-986504 + Pumitamig + Chemotherapy
Drug: Carboplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
Experimental: Part 2: Cohort 3
BMS-986504 + Nivolumab + Relatlimab FDC
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Nivolumab + Relatlimab FDC
Specified dose on specified days
Experimental: Part 2: Cohort 4
BMS-986504 + Temozolomide + Radiotherapy
Drug: Temozolomide
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 1a
BMS-986504
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 1b
BMS-986504
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 2: Cohort 2a
BMS-986504 + Daraxonrasib
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236
Experimental: Part 2: Cohort 2b
BMS-986504 + Daraxonrasib
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236
Experimental: Part 2: Cohort 2c
BMS-986504 + Daraxonrasib + Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants who achieve Objective Response (OR)
Time Frame: Up to approximately 2 years
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
Up to approximately 2 years
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Time to objective response (TTOR)
Time Frame: Up to approximately 2 years
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
Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Time Frame: Up to approximately 2 years
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
Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Time Frame: Up to approximately 2 years
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
Up to approximately 2 years
Part 1: Number of participants with adverse events (AE)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with Serious AEs (SAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with treatment related AEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with treatment related SAEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with AEs leading to study treatment discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with laboratory abnormalities
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants who achieve Objective Response (OR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1 and 2: Number of participants who achieved clinical benefit (CB)
Time Frame: Up to approximately 2 years
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
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2026

Primary Completion (Estimated)

August 15, 2028

Study Completion (Estimated)

May 20, 2032

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA240-0005
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524285-18 (Other Identifier: EU CTR)
  • U1111-1330-1428 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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