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OMO-103 for Locally Advanced or Metastatic Pancreatic Cancer

This study is testing a drug called OMO-103 for people with pancreatic cancer that has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic). OMO-103 works by potentially stopping the growth of cancer cells. Researchers want to see how OMO-103 changes pancreatic tumor cells. You may be able to join if you are 18 or older, have a confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma, and meet other health requirements. The main goal is to see how OMO-103 affects the tumor's biology. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is an interventional study with a planned enrollment of 12 participants. The phase of the study is not specified.
What's involved
You would receive OMO-103 intravenously on days 1 and 8. You would also undergo CT or MRI scans, tumor biopsies, and blood sample collections throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up at 30 days and then for 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07089940

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
OHSU Knight Cancer Institute
~12 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingMyc Inhibitor OMO-103

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurable change in tumor biology
Measured over Time of pretreatment biopsy (baseline) to completion of post-treatment biopsy

Conditions

Locally Advanced Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8

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Pancreatic Ductal Adenocarcinoma

NCT07089940

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OHSU Knight Cancer Institute

    Portland, Oregonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Charles D Lopez · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Charles D. Lopez
[email protected]
503-494-8534
Email the study team

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Eligibility criteria

Inclusion

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
Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after completing the most recent line of therapy is required before a participant can initiate treatment with study agent(s)
Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards
Patient agrees to undergo a minimum of 2 biopsies (pre- and post-treatment). Note: at principal investigator (PI) discretion, archival sample may be obtained in lieu of pre-treatment biopsy
Hemoglobin ≥ 7.5 g/dL
Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L (\> 1500 per mm\^3)
Platelet count ≥ 75 x 10\^9/L (\> 100,000 per mm\^3)
Calculated creatinine clearance \> 50 mL/min/1.73m\^2 (per Cockcroft-Gault equation)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN in presence of liver metastases
Participants of childbearing potential (POCBP) must agree to abstain from sexual intercourse or use effective methods of contraception starting with the first dose of study therapy through 6 months from the last dose of study intervention
POCBP may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 7 days of starting treatment
Sperm-producing participants must agree to abstain from sexual intercourse or use effective contraception starting with the first dose through 6 months after last dose of study intervention

Exclusion

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
Major surgery within 6 weeks prior to enrollment
Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiating study intervention
History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements

What this trial measures

  • Measurable change in tumor biologyTime of pretreatment biopsy (baseline) to completion of post-treatment biopsy

    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.