Locally Advanced Pancreatic Ductal AdenocarcinomaEarly Phase 1NCT07089940
OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
A Early Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Locally Advanced Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 31 Dec 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Charles D. Lopez, 503-494-8534, lopezc@ohsu.edu
Charles D. Lopez
About this study
Official title: An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the pharmacodynamic effects of Myc inhibitor OMO-103 (OMO-103) in tumor biopsies from patients with pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVE:
- To assess safety and tolerability of the proposed therapy.
EXPLORATORY OBJECTIVE:
- To identify predictive biomarkers of sensitivity to therapy.
OUTLINE:
Patients receive OMO-103 intravenously (IV) over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI), tumor biopsies, and collection of blood samples throughout the study.
After completion of study treatment, patients are followed up at 30 days and then for 1 year.
- 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
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Myc Inhibitor OMO-103
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Myc Inhibitor OMO-103Drug
Also called OMO 103, OMO-103, OMO103
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (OMO-103) | Experimental | Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Myc Inhibitor OMO-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 (i.e., start of study intervention) up to 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start27 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, Brendon-Colson Center, Peptomyc S.L.
- Responsible party
- Principal investigator, Charles D Lopez, OHSU Knight Cancer Institute
- Investigators
- Charles D Lopez, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089940
- Sponsor's protocol ID
- STUDY00027995
- Other IDs
- NCI-2025-05087, STUDY00027995
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No