Early Phase 1 Study of OMO-103 Given by IV to Treat Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread locally or to other parts of the body. This early phase 1 trial aims to study how OMO-103, which may block enzymes important for tumor growth, affects pancreatic tumor cells. The study also looks at safety, tolerability, and biomarkers that might predict response to the therapy. Participants receive OMO-103 through an intravenous infusion lasting 30 to 45 minutes on days 1 and 8, as long as the disease does not progress and side effects are manageable. During the study, patients undergo imaging tests such as CT or MRI scans, tumor biopsies before and after treatment, and blood sample collections to monitor effects and changes. After completing the treatments, participants are followed up once 30 days later and then monitored for one year. Researchers measure changes in tumor biology between biopsies taken before and after treatment, and track any treatment-related adverse events from the start of therapy to 30 days after the last dose. The total time of involvement includes treatment and extended follow-up for safety and outcomes.

OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma