Recruiting

Phase 2

BMS-986504A 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)

Sponsor:

Bristol-Myers Squibb

Code:

NCT07492680

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986504

Daraxonrasib

Nivolumab + Relatlimab FDC

Temozolomide

Pumitamig

Study Details

Brief 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.

Conditions

Solid Tumors

Study ID

NCT07492680

Start date

Jul 27, 2026

Status verified date

Oct, 2026

Completion date

May 20, 2032

Anticipated

Primary completion date

Aug 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a

BMS-986504

experimental: Part 1b

BMS-986504

experimental: Part 2: Cohort 1

BMS-986504 + Pumitamig + Chemotherapy

experimental: Part 2: Cohort 2a

BMS-986504 + Daraxonrasib

experimental: Part 2: Cohort 2b

BMS-986504 + Daraxonrasib

experimental: Part 2: Cohort 2c

BMS-986504 + Daraxonrasib + Chemotherapy

experimental: Part 2: Cohort 3

BMS-986504 + Nivolumab + Relatlimab FDC

experimental: Part 2: Cohort 4

BMS-986504 + Temozolomide + Radiotherapy

Interventions

BMS-986504