BMS-986504 + Pemetrexed

PRIMARY OBJECTIVE: I. To assess the safety, tolerability and dose limiting toxicity (DLT) of PRMT5 inhibitor BMS-986504 (BMS-986504) in patients with metastatic solid tumors with homozygous deletion of the MTAP gene treated with BMS-986504 in combination with pemetrexed. SECONDARY OBJECTIVES: I. To assess the overall response rate (ORR) in patients with metastatic solid tumors homozygous deletion of the MTAP gene treated with BMS-986504 in combination with pemetrexed. II.

To assess the duration of response (DOR) among patients achieving an objective response, defined as the time from first documented response to disease progression or death. EXPLORATORY OBJECTIVES: I. To descriptively summarize overall survival (OS) in the treated population. II. To descriptively summarize progression-free survival (PFS) in the treated population. III. To descriptively assess the pharmacokinetics of BMS-986504 in combination with pemetrexed.

Giving BMS-986504 in combination with pemetrexed may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors with MTAP deletion.

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.

Registro actualizado en ClinicalTrials.gov →

• 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

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.