Actively Recruiting
An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma
Led by OHSU Knight Cancer Institute · Updated on 2026-03-23
12
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread locally or to other parts of the body. This early phase 1 trial aims to study how OMO-103, which may block enzymes important for tumor growth, affects pancreatic tumor cells. The study also looks at safety, tolerability, and biomarkers that might predict response to the therapy. Participants receive OMO-103 through an intravenous infusion lasting 30 to 45 minutes on days 1 and 8, as long as the disease does not progress and side effects are manageable. During the study, patients undergo imaging tests such as CT or MRI scans, tumor biopsies before and after treatment, and blood sample collections to monitor effects and changes. After completing the treatments, participants are followed up once 30 days later and then monitored for one year. Researchers measure changes in tumor biology between biopsies taken before and after treatment, and track any treatment-related adverse events from the start of therapy to 30 days after the last dose. The total time of involvement includes treatment and extended follow-up for safety and outcomes.
CONDITIONS
Brief 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-specific procedures or interventions
- Must be 18 years old or older at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Clinically confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma
- Participants may be treatment naive or previously treated with at least a 14-day washout after last therapy
- Must have at least one disease lesion suitable for biopsy
- Agree to undergo at least two biopsies (pre- and post-treatment), or provide archival sample if allowed
- Hemoglobin level of 7.5 g/dL or higher
- Absolute neutrophil count of 1.0 x 10^9/L or higher
- Platelet count of 75 x 10^9/L or higher
- Calculated creatinine clearance greater than 50 mL/min/1.73m^2
- AST/ALT levels less than or equal to 3 times the upper limit of normal, or up to 5 times if liver metastases are present
- Participants of childbearing potential must agree to abstain or use effective contraception from first dose through 6 months after last dose
- Negative pregnancy test required for participants of childbearing potential
- Sperm-producing participants must agree to abstain or use effective contraception from first dose through 6 months after last dose
You will not qualify if you...
- Use of other anti-cancer therapies not permitted by the protocol
- Anti-cancer therapy within 2 weeks prior to enrollment
- Prior treatment with a MYC inhibitor
- Known severe allergy to OMO-103 or related compounds
- Major surgery within 6 weeks before enrollment
- Uncontrolled illnesses including certain heart conditions within 3 months before study
- Psychiatric illness interfering with consent or protocol compliance
- Pregnant or breastfeeding, or planning conception during the trial and 6 months after
- Investigator judgment that patient may not comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 days
Participants receive the drug OMO-103 intravenously on days 1 and 8. During this period, they undergo CT or MRI scans, tumor biopsies, and blood sample collections.
2 infusion visits and multiple visits for imaging, biopsies, and blood collection
Duration - 1 year and 1 month
After treatment completion, participants are followed up at 30 days and then for 1 year to monitor safety and health status.
1 visit at 30 days post-treatment and additional visits over 1 year
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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