Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07089940

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

Led by OHSU Knight Cancer Institute · Updated on 2026-03-23

12

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

O

OHSU Knight Cancer Institute

Lead Sponsor

O

Oregon Health and Science University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must provide written informed consent before any study procedures
  • Must be 18 years or older at the time of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Confirmed diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma
  • May be treatment-naïve or have received prior therapy with at least 14-day washout
  • At least one disease lesion suitable for biopsy
  • Agree to undergo at least two biopsies (pre- and post-treatment)
  • Hemoglobin level of at least 7.5 g/dL
  • Absolute neutrophil count of at least 1.0 x 10^9/L
  • Platelet count of at least 75 x 10^9/L
  • Creatinine clearance above 50 mL/min/1.73m^2
  • AST/ALT levels not exceeding 3 times upper limit of normal or 5 times if liver metastases present
  • Participants of childbearing potential must use effective contraception or abstain from sex during treatment and for 6 months after
  • Negative pregnancy test required before treatment for participants of childbearing potential
  • Sperm-producing participants must use contraception or abstain during treatment and for 6 months after
Not Eligible

You will not qualify if you...

  • Use of other anti-cancer therapies not allowed by the protocol
  • Anti-cancer therapy within 2 weeks before enrollment
  • Prior treatment with a MYC inhibitor
  • Severe allergy to OMO-103 or related compounds
  • Major surgery within 6 weeks before enrollment
  • Uncontrolled illnesses such as symptomatic heart failure, unstable angina, arrhythmia, or recent heart attack within 3 months
  • Psychiatric illness interfering with study compliance or consent
  • Pregnancy, breastfeeding, or planning to conceive/father children during the study and 6 months after
  • Investigator judgment that patient is unlikely to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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