NCT07089940

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

An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial may help researchers determine how exposure to OMO-103 changes pancreatic tumor cells.

Detailed description

PRIMARY OBJECTIVE: I. To assess the pharmacodynamic effects of Myc inhibitor OMO-103 (OMO-103) in tumor biopsies from patients with pancreatic ductal adenocarcinoma (PDAC). SECONDARY OBJECTIVE: I. To assess safety and tolerability of the proposed therapy. EXPLORATORY OBJECTIVE: I. To identify predictive biomarkers of sensitivity to therapy. OUTLINE: Patients receive OMO-103 intravenously (IV) over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI), tumor biopsies, and collection of blood samples throughout the study. After completion of study treatment, patients are followed up at 30 days and then for 1 year.

Conditions

• Locally Advanced Pancreatic Ductal Adenocarcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Myc Inhibitor OMO-103	Given IV

Timeline

• Start date: 2026-01-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-29
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study