BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion
NCT07594626 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2026-05-19
Summary
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.
Conditions
- Metastatic Biliary Tract Carcinoma
- Metastatic Colon Carcinoma
- Metastatic Esophageal Carcinoma
- Metastatic Malignant Digestive System Neoplasm
- Metastatic Malignant Solid Neoplasm
- Metastatic Pancreatic Carcinoma
- Stage IV Colon Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Computed Tomography
Undergo CT
- DRUG
-
Pemetrexed
Given IV
- DRUG
-
PRMT5 Inhibitor BMS-986504
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Devalingam Mahalingam, MD, PhD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-12-09
- Primary Completion
- 2030-12-09
- Completion
- 2030-12-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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