Health TrialsbyHealthPanel

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

ConditionsLocally Advanced Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Myc Inhibitor OMO-103

    Drug

    Given IV

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Treatment (OMO-103)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Measurable 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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Brendon-Colson Center

Collaborator

Peptomyc S.L.

Collaborator

Source ClinicalTrials.gov
Apply now