BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07594626
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Pemetrexed — DRUG
    Given IV
  • PRMT5 Inhibitor BMS-986504 — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 9, 2027
Status verified
May 2026
Primary completion
Dec 9, 2030
Completion
Dec 9, 2030

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (BMS-986504, pemetrexed)
    Patients receive BMS-986504 PO QD on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT throughout the study.

Primary Outcome Measure

Dose limiting toxicity [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Devalingam Mahalingam, MD, PhD
[email protected]
210-413-1723
Devalingam Mahalingam, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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