Recruiting
Early Phase 1

OMO-103

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07089940

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Myc Inhibitor OMO-103

Study Details

Brief 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). 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

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

Study ID

NCT07089940

Start date

Jan 27, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (OMO-103)

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.

Interventions

Biopsy Procedure

Undergo tumor biopsy

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Myc Inhibitor OMO-103

Given IV

Primary outcome measure

  • Measurable change in tumor biology [ Time Frame: Time of pretreatment biopsy (baseline) to completion of post-treatment biopsy ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Charles D. Lopez

503-494-8534lopezc@ohsu.edu

Principal Investigator:

Charles D. Lopez

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-03-23.