Navlimetostat alone or with other cancer drugs for advanced solid tumors with MTAP deletion
Tests navlimetostat, alone or combined, in adults with advanced tumors lacking MTAP.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Cork and Dublin, IrelandSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread solid tumors that lack the MTAP gene (homozygous deletion) or have lost MTAP. They test navlimetostat alone or with other cancer drugs.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Advanced and/or metastatic solid tumor, confirmed under the microscope, with at least one tumor that can be measured on scans. ECOG performance status 0 or 1.
- Earlier treatment
- Depending on the cohort: either standard treatments for the tumor type, with the disease growing during or after the latest one, or no earlier systemic cancer treatment for the unresectable or spread disease.
- Biomarker or test result
- Homozygous deletion of the MTAP gene, or MTAP loss, found in tumor tissue.
Main reasons for not taking part
- Earlier treatment with a PRMT5 or MAT2A inhibitor
- Active brain metastases or carcinomatous meningitis
- Stomach or bowel disease within 6 months that could affect absorption of oral medicine or swallowing
- Poor organ function on screening tests
- Active viral hepatitis B or C
Read by machine on 9 November 2026.
Where in Ireland
- Cork University HospitalCork, IrelandTaking people
- DublinHospital not named in the registryNot yet recruiting
- Mater Misericordiae University Hospital (MMUH)Dublin, IrelandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07492680
- Record updated
- 4 November 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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 active viral HBV or HCV hepatitis; Participants must not have inadequate organ function, as determined by laboratory testing within the screening period; Other protocol defined inclusion/exclusion criteria applies.