Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
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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