A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advan… (NCT07492680) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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)
United States260 participantsStarted 2026-07-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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-naĂŻve 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
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 (o…
What they're measuring
1
Part 1: Number of participants who achieve Objective Response (OR)
Timeframe: Up to approximately 2 years
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
Trial details
NCT IDNCT07492680
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2032-05-20
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com