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
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
260
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Lead sponsor
Bristol-Myers Squibb
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Start date
2026-07-27
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Number of sites
58
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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.
clinicaltrials.gov
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)
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2032-05-20
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First posted
2026-03-25
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Registry last updated
2026-10-06
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Primary completion date
2028-08-15
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Start date
2026-07-27
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Participants
260
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Participant count basis
Estimated
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Planned participants
260
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Protocol amendments
1
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Number of sites
58
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07492680
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ClinicalTrials.gov ID
NCT07492680
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • U1111-1330-1428
  • 2025-524285-18
Sources for references
clinicaltrials.gov

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