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Bristol-Myers SquibbA 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) Phase 2 260 Open-Label
Clinical Trial NCT07492680 is designed to study Treatment for Solid Tumors. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on July 17, 2026 until the study accrues 260 participants. Led by Bristol-Myers Squibb, this study is expected to complete by May 20, 2032. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
Brief Summary
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-98650...Show More
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.
Official Title
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
Conditions
Solid TumorsOther Study IDs
- CA240-0005
- 2025-524285-18 (Other Identifier) (EU CTR)
- U1111-1330-1428 (Other Identifier) (WHO)
NCT ID Number
Start Date (Actual)
2026-07-17
Last Update Posted
2026-03-25
Completion Date (Estimated)
2032-05-20
Enrollment (Estimated)
260
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
MTAP
CDKN2A
PRMT5
MountainTAP
Targeted therapy
Brain cancer
GBM
Melanoma
NSCLC
Lung cancer PDAC
Pancreatic cancer
Navlimetostat
Navli
CDKN2A
PRMT5
MountainTAP
Targeted therapy
Brain cancer
GBM
Melanoma
NSCLC
Lung cancer PDAC
Pancreatic cancer
Navlimetostat
Navli
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart 1a | BMS-986504 Specified dose on specified days |
ExperimentalPart 1b | BMS-986504 Specified dose on specified days |
ExperimentalPart 2: Cohort 1 BMS-986504 + Pumitamig + Chemotherapy | BMS-986504 Specified dose on specified days Pumitamig Specified dose on specified days Pemetrexed Specified dose on specified days Carboplatin Specified dose on specified days Nab-paclitaxel Specified dose on specified days Paclitaxel Specified dose on specified days |
ExperimentalPart 2: Cohort 2a BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
ExperimentalPart 2: Cohort 2b BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
ExperimentalPart 2: Cohort 2c BMS-986504 + Pan-RAS inhibitor + Chemotherapy | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days Nab-paclitaxel Specified dose on specified days Gemcitabine Specified dose on specified days |
ExperimentalPart 2: Cohort 3 BMS-986504 + Nivolumab + Relatlimab FDC | BMS-986504 Specified dose on specified days Nivolumab + Relatlimab FDC Specified dose on specified days |
ExperimentalPart 2: Cohort 4 BMS-986504 + Temozolomide + Radiotherapy | BMS-986504 Specified dose on specified days Temozolomide Specified dose on specified days |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Up to approximately 2 years |
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria | Up to approximately 2 years | |
Part 2: Number of participants with adverse events (AE) | Up to approximately 2 years | |
Part 2: Number of participants with Serious AEs (SAEs) | Up to approximately 2 years | |
Part 2: Number of participants with treatment related AEs | Up to approximately 2 years | |
Part 2: Number of participants with treatment related SAEs | Up to approximately 2 years | |
Part 2: Number of participants with AEs leading to study treatment discontinuation | Up to approximately 2 years | |
Part 2: Number of participants with AEs leading to death | Up to approximately 2 years | |
Part 2: Number of participants with laboratory abnormalities | Up to approximately 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Up to approximately 2 years |
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 | Up to approximately 2 years |
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 | Up to approximately 2 years |
Part 1: Number of participants with adverse events (AE) | Up to approximately 2 years | |
Part 1: Number of participants with Serious AEs (SAEs) | Up to approximately 2 years | |
Part 1: Number of participants with treatment related AEs | Up to approximately 2 years | |
Part 1: Number of participants with treatment related SAEs | Up to approximately 2 years | |
Part 1: Number of participants with AEs leading to study treatment discontinuation | Up to approximately 2 years | |
Part 1: Number of participants with AEs leading to death | Up to approximately 2 years | |
Part 1: Number of participants with laboratory abnormalities | Up to approximately 2 years | |
Part 2: Number of participants who achieve Objective Response (OR) | Up to approximately 2 years | |
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 | Up to approximately 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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) should be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer should be ≤ 2 × ULN.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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 (eg, uncontrolled nausea, vomiting, malabsorption syndrome) 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.
Bristol-Myers SquibbStudy Central Contact
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
55 Study Locations in 13 Countries
California
Local Institution - 0096, San Francisco, California, 94158, United States
Site 0096, Contact
Colorado
Local Institution - 0182, Aurora, Colorado, 80045, United States
Site 0182, Contact
Florida
Local Institution - 0122, Tampa, Florida, 33612, United States
Georgia
Local Institution - 0178, Atlanta, Georgia, 30322, United States
Site 0178, Contact
Illinois
Local Institution - 0106, Chicago, Illinois, 60637, United States
Site 0106, Contact
Maryland
Local Institution - 0143, Baltimore, Maryland, 21287, United States
Site 0143, Contact
Massachusetts
Local Institution - 0124, Boston, Massachusetts, 02114, United States
Site 0124, Contact
Michigan
Local Institution - 0119, Ann Arbor, Michigan, 48109-0922, United States
Site 0119, Contact
Minnesota
Local Institution - 0129, Rochester, Minnesota, 55905, United States
Site 0129, Contact
Local Institution - 0174, Rochester, Minnesota, 55905, United States
Site 0174, Contact
Local Institution - 0181, Rochester, Minnesota, 55905, United States
Site 0181, Contact
New York
Local Institution - 0142, Buffalo, New York, 14263, United States
Site 0142, Contact
Local Institution - 0170, New York, New York, 10016, United States
Site 0170, Contact
Local Institution - 0139, New York, New York, 10021, United States
Site 0139, Contact
North Carolina
Local Institution - 0100, Durham, North Carolina, 27705, United States
Site 0100, Contact
Texas
Local Institution - 0085, Houston, Texas, 77030, United States
Site 0085, Contact
Washington
Local Institution - 0086, Seattle, Washington, 98109, United States
Site 0086, Contact
Wisconsin
Local Institution - 0134, Madison, Wisconsin, 53792, United States
Site 0134, Contact
British Columbia
Local Institution - 0051, Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Site 0051, Contact
Ontario
Local Institution - 0021, Toronto, Ontario, M4N 3M5, Canada
Site 0021, Contact
Local Institution - 0007, Toronto, Ontario, M5G 2M9, Canada
Site 0007, Contact
Oost-Vlaanderen
Local Institution - 0114, Ghent, Oost-Vlaanderen, 9000, Belgium
Site 0114, Contact
Beijing Municipality
Local Institution - 0155, Beijing, Beijing Municipality, 100071, China
Site 0155, Contact
Shanghai Municipality
Local Institution - 0153, Shanghai, Shanghai Municipality, 200032, China
Site 0153, Contact
Local Institution - 0156, Shanghai, Shanghai Municipality, 200131, China
Site 0156, Contact
Côte-d'Or
Local Institution - 0078, Dijon, Côte-d'Or, 21079, France
Site 0078, Contact
Rhône
Local Institution - 0075, Pierre-Bénite, Rhône, 69310, France
Site 0075, Contact
Val-de-Marne
Local Institution - 0116, Villejuif, Val-de-Marne, 94800, France
Site 0116, Contact
Local Institution - 0074, Paris, 75010, France
Site 0074, Contact
Rhineland-Palatinate
Local Institution - 0081, Mainz, Rhineland-Palatinate, 55131, Germany
Site 0081, Contact
Local Institution - 0040, Hamburg, 20246, Germany
Site 0040, Contact
Local Institution - 0039, Heidelberg, 69120, Germany
Site 0039, Contact
Local Institution - 0061, Leipzig, 04103, Germany
Site 0061, Contact
Local Institution - 0049, München, 81675, Germany
Site 0049, Contact
Local Institution - 0047, Würzburg, 97080, Germany
Site 0047, Contact
Local Institution - 0063, Shatin, NT, Hong Kong
Site 0063, Contact
Local Institution - 0080, Cork, T12 E8YV, Ireland
Site 0080, Contact
Local Institution - 0023, Dublin, 7, Ireland
Site 0023, Contact
Local Institution - 0146, Dublin, D08 E9P6, Ireland
Site 0146, Contact
Tuscany
Local Institution - 0073, Siena, Tuscany, 53100, Italy
Site 0073, Contact
Local Institution - 0123, Bergamo, 24127, Italy
Site 0123, Contact
Local Institution - 0034, Milan, 20133, Italy
Site 0034, Contact
Local Institution - 0050, Naples, 80131, Italy
Site 0050, Contact
Local Institution - 0082, Perugia, 06156, Italy
Site 0082, Contact
Tokyo
Local Institution - 0020, Chuo-ku, Tokyo, 104-0045, Japan
Site 0020, Contact
Hordaland
Local Institution - 0171, Bergen, Hordaland, 5021, Norway
Site 0171, Contact
Local Institution - 0022, Oslo, 0450, Norway
Site 0022, Contact
Seoul-teukbyeolsi [Seoul]
Local Institution - 0004, Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Site 0004, Contact
Local Institution - 0058, Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Site 0058, Contact
Local Institution - 0052, Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Site 0052, Contact
Barcelona [Barcelona]
Local Institution - 0068, Barcelona, Barcelona [Barcelona], 08035, Spain
Site 0068, Contact
Local Institution - 0071, Hospitalet, Barcelona [Barcelona], 08907, Spain
Site 0071, Contact
Local Institution - 0033, Madrid, 28028, Spain
Site 0033, Contact
Local Institution - 0059, Madrid, 28034, Spain
Site 0059, Contact
Local Institution - 0069, Seville, 41013, Spain
Site 0069, Contact