BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This phase Ib/II trial tests the safety and side effects of BMS-986504 in combination with pemetrexed and how well the combination works in treating patients with solid tumors with MTAP deletion and that has spread from where it first started (primary site) to other places in the body (metastatic). The MTAP gene helps cells recycle important parts needed to make deoxyribonucleic acid (DNA), which is needed for cell growth and function. MTAP deletion means that the MTAP gene is missing. BMS-986504, a PRMT5 inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Giving BMS-986504 in combination with pemetrexed may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors with MTAP deletion.
Sponsor: Northwestern University
You may qualify if…
- ✓ COHORT A (INCLUDING SAFETY RUN IN, STAGE I AND STAGE II) AND COHORT B:
- ✓ Patients must have pathologically or cytologically confirmed metastatic solid tumor of gastrointestinal origin with MTAP deletion including pancreatic cancer, biliary cancer, esophageal cancer and colon cancer (Cohort A) or other metastatic solid malignancy with MTAP deletion (Cohort B) confirmed by validated next generation sequencing tissue techniques only
- ✓ NOTE: Both internal and external validated next generation sequencing (NGS) panels are acceptable
- ✓ Progressive disease (PD) after one previous standard of care line of treatment
- ✓ NOTE: symptoms from clinical evaluation for PD will be sufficient
- ✓ Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, measured preferably by computed tomography (CT) scan
- ✓ Note: Tumor lesions in a previously irradiated area are not considered measurable unless they show unequivocal progression
- ✓ NOTE: There is no limit on previous treatment lines
You may not qualify if…
- ✕ STAGE I AND II, COHORT A (INCLUDING SAFETY RUN IN) AND B:
- ✕ Patients who received prior pemetrexed containing chemotherapy (apart from NSCLC)
- ✕ Patients with prior treatment with a PRMT5 or MAT2A inhibitor therapy
- ✕ Patients with pre-existing clinically significant interstitial lung disease (ILD)
- ✕ Patients who have had chemotherapy or radiotherapy ≤ 21 days prior to planned treatment start date.
- ✕ Note: seven days or fewer of palliative radiotherapy for non-CNS disease, is permitted. No wash-out is required
- ✕ Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- ✕ Patients who are receiving any other investigational agents or devices. Patients start of study treatment will be based on their discontinuation and recovery from clinically significant adverse events from their most recent therapy or intervention prior to study enrollment
Where it's recruiting
Chicago
Source: ClinicalTrials.gov · NCT07594626 · last updated 2026-08-25