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Taking people in SpainPhase 2

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.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Barcelona, Hospitalet, Madrid, and Seville, SpainSee the 4 sitesAlso in 12 other countries, 54 sites
Trial code
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)
Status
Recruiting
Phase
Phase 2
People taking part
254 people, planned
Started
27 Jul 2026
Expected to end
20 May 2032
Type of study
Interventional, 7 groups
Treatments tested
  • Navlimetostat
  • Daraxonrasib
  • Temozolomide
  • Pumitamig
  • Pemetrexed
  • Carboplatin
  • Nab-paclitaxel
  • Gemcitabine
  • Paclitaxel
  • Cisplatin
Record updated
4 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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 take part

  • 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

Where in Spain

Also in 12 other countries, 54 sites

  • Hospital Universitari Vall d'HebronBarcelona, SpainContact: Irene Brana Garcia, Site 0068Taking people
  • Hospitalet, Barcelona [Barcelona]Hospital not named in the registryContact: Site 0071Not yet recruiting
  • Hospital General Universitario Gregorio MarañónMadrid, SpainContact: Ivan Marquez Rodas, Site 0033Taking people
  • Hospital Universitario Virgen del RocioSeville, SpainContact: FATIMA TOSCANO, Site 0069Taking people

About the trial

What the trial wants to find out

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.

The 7 groups in the trial

  • Part 1aTreatment being tested

    Navlimetostat (BMS-986504)

    Treatment: Navlimetostat

  • Part 1bTreatment being tested

    Navlimetostat (BMS-986504)

    Treatment: Navlimetostat

  • Part 2: Cohort 1Treatment being tested

    Navlimetostat (BMS-986504) + Pumitamig + Chemotherapy

    Treatment: Navlimetostat, Pumitamig, Pemetrexed, Carboplatin, Nab-paclitaxel, Paclitaxel, and Cisplatin

  • Part 2: Cohort 2aTreatment being tested

    Navlimetostat (BMS-986504) + Daraxonrasib

    Treatment: Navlimetostat and Daraxonrasib

  • Part 2: Cohort 2bTreatment being tested

    Navlimetostat (BMS-986504) + Daraxonrasib

    Treatment: Navlimetostat and Daraxonrasib

  • Part 2: Cohort 2cTreatment being tested

    Navlimetostat (BMS-986504) + Daraxonrasib + Chemotherapy

    Treatment: Navlimetostat, Daraxonrasib, Nab-paclitaxel, and Gemcitabine

  • Part 2: Cohort 4Treatment being tested

    Navlimetostat (BMS-986504) + Temozolomide + Radiotherapy

    Treatment: Navlimetostat and Temozolomide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Navlimetostat alone or with other cancer drugs for advanced solid tumors with MTAP deletionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
4 November 2026