> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bms-986504-monotherapy-and-in-combination-with-2656535e-05ee-4290-8b91-ca59f4ae68ce > Record changed: 2026-11-04 # 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) NCT07492680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Participants 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Start date 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) Number of sites 58 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Title and summary **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-986504 alone and in combination regimens. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Dates **Completion date** 2032-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **First posted** 2026-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Primary completion date** 2028-08-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Start date** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Size and sites **Participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Planned participants** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Number of sites** 58 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Identifiers **Registry ID** NCT07492680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **ClinicalTrials.gov ID** NCT07492680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Outcomes ### Primary outcomes 1. Part 1: Number of participants who achieve Objective Response (OR) Timeframe: 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 2. Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria Timeframe: Up to approximately 2 years 3. Part 2: Number of participants with adverse events (AE) Timeframe: Up to approximately 2 years 4. Part 2: Number of participants with Serious AEs (SAEs) Timeframe: Up to approximately 2 years 5. Part 2: Number of participants with treatment related AEs Timeframe: Up to approximately 2 years 6. Part 2: Number of participants with treatment related SAEs Timeframe: Up to approximately 2 years 7. Part 2: Number of participants with AEs leading to study treatment discontinuation Timeframe: Up to approximately 2 years 8. Part 2: Number of participants with AEs leading to death Timeframe: Up to approximately 2 years 9. Part 2: Number of participants with laboratory abnormalities Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Part 1 and 2: Time to objective response (TTOR) Timeframe: 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 2. Part 1 and 2: Duration of response (DOR) Timeframe: 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 3. Part 1 and 2: Number of participants who achieve disease control (DC) Timeframe: 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 4. Part 1: Number of participants with adverse events (AE) Timeframe: Up to approximately 2 years 5. Part 1: Number of participants with Serious AEs (SAEs) Timeframe: Up to approximately 2 years 6. Part 1: Number of participants with treatment related AEs Timeframe: Up to approximately 2 years 7. Part 1: Number of participants with treatment related SAEs Timeframe: Up to approximately 2 years 8. Part 1: Number of participants with AEs leading to study treatment discontinuation Timeframe: Up to approximately 2 years 9. Part 1: Number of participants with AEs leading to death Timeframe: Up to approximately 2 years 10. Part 1: Number of participants with laboratory abnormalities Timeframe: Up to approximately 2 years 11. Part 2: Number of participants who achieve Objective Response (OR) Timeframe: Up to approximately 2 years 12. Part 1 and 2: Number of participants who achieved clinical benefit (CB) Timeframe: 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Sites - Local Institution - 0096San Francisco, United StatesNot yet recruiting - Local Institution - 0182Aurora, United StatesNot yet recruiting - Emory University - Winship Cancer InstituteAtlanta, United StatesRecruiting - Johns Hopkins HospitalBaltimore, United StatesRecruiting - Local Institution - 0124Boston, United StatesNot yet recruiting - Local Institution - 0119Ann Arbor, United StatesNot yet recruiting - Local Institution - 0129Rochester, United StatesNot yet recruiting - Local Institution - 0174Rochester, United StatesNot yet recruiting - Local Institution - 0181Rochester, United StatesNot yet recruiting - Local Institution - 0142Buffalo, United StatesNot yet recruiting - Local Institution - 0170New York, United StatesNot yet recruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Local Institution - 0100Durham, United StatesNot yet recruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Local Institution - 0086Seattle, United StatesNot yet recruiting - Local Institution - 0134Madison, United StatesNot yet recruiting - UZ BrusselBrussels, BelgiumRecruiting - Cliniques universitaires Saint-LucBrussels, BelgiumRecruiting - UZ GentGhent, BelgiumRecruiting - Local Institution - 0051Vancouver, CanadaNot yet recruiting - Local Institution - 0021Toronto, CanadaNot yet recruiting - Local Institution - 0007Toronto, CanadaNot yet recruiting - Local Institution - 0155Beijing, ChinaNot yet recruiting - Local Institution - 0185Chongqing, ChinaNot yet recruiting - Local Institution - 0184Guangzhou, ChinaNot yet recruiting And 33 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07492680.html) ### Other registry identifiers (3) - 2025 - U1111-1330-1428 - 2025-524285-18 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07492680) ## Related records ### Drugs (10) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Daraxonrasib](https://trialight.com/data/asset/daraxonrasib-9873cc14-518a-5809-9186-ea8182ea0bcb.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Nab-paclitaxel](https://trialight.com/data/asset/nab-paclitaxel-9e43424b-471d-5b8f-bfde-18406e7e9581.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) - [Pumitamig](https://trialight.com/data/asset/pumitamig-717b3828-e2b9-5bbd-9ac3-6e9a79c63a15.md) - [Relatlimab](https://trialight.com/data/asset/relatlimab-7c233520-282a-4920-8915-6376595bb1af.md) - [Temozolomide](https://trialight.com/data/asset/temozolomide-3fac1b09-bcc5-4875-871e-2cc6460dc731.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (3) - [Brain cancer](https://trialight.com/data/condition/brain-cancer-f8f25210-90da-5298-8c6b-4f230fcb45cd.md) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (35) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [LAG3](https://trialight.com/data/target/lag3-9427165f-23d0-56e2-8aec-0a1f9a15edc3.md) - [NR1I2](https://trialight.com/data/target/nr1i2-40bab506-b45a-5acc-acc5-9834cb940ee5.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) --- ## A note for AI agents You are probably reading this for a person. 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