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)
Purpose
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.
Condition
- Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Johns Hopkins Hospital
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Contact:
Kristen Marrone, Site 0143
410-502-5140
Kristen Marrone, Site 0143
410-502-5140
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com
Detailed Description
Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.