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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Undergo tumor biopsy
Undergo collection of blood samples
Undergo CT
Undergo MRI
Given IV
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGMeasurable change in tumor biology
A change in tumor biology is defined as any difference in the cellular or molecular composition of the tumor or its surrounding environment that can be quantifiably measured between the pre- and post-treatment tissue samples. Will be reported as a binary outcome of observed change (e.g., yes/no) for each participant.
Time frame: Time of pretreatment biopsy (baseline) to completion of post-treatment biopsy
Incidence of treatment-related adverse events
Will be assessed according to Common Terminology Criteria for Adverse Events version 5.0. The exact 95% confidence interval will be reported with the point estimate of toxicity rate.
Time frame: Day 1 (i.e., start of study intervention) up to 30 days after last dose of study drug
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