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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy, or other novel agent

Prior anti-cancer therapy within 2 weeks prior to study enrollment

Prior treatment with a MYC inhibitor

Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Myc Inhibitor OMO-103

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Brendon-Colson Center

Collaborator

Peptomyc S.L.

Collaborator