An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma
OHSU Knight Cancer Institute
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must provide written informed consent before any study-specific procedures or interventions are performed * Must be ≥ 18 years old at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas * Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after completing the most recent line of therapy is required before a participant can initiate treatment…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugMyc Inhibitor OMO-103
Given IV
Location
- OHSU Knight Cancer InstitutePortland, Oregon