Health Trials

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

ConditionsMetastatic Biliary Tract CarcinomaMetastatic Colon CarcinomaMetastatic Esophageal CarcinomaMetastatic Malignant Digestive System NeoplasmMetastatic Malignant Solid NeoplasmMetastatic Pancreatic CarcinomaStage IV Colon Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Pemetrexed
  • PRMT5 Inhibitor BMS-986504

Treatment groups

72 Participants
are divided into 1 treatment group

Sponsors and collaborators

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov