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

Not Applicable

Not yet recruiting

• 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
• Interventions: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Myc Inhibitor OMO-103

• Registration Number: NCT07089940
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the pharmacodynamic effects of Myc inhibitor OMO-103 (OMO-103) in tumor biopsies from patients with pancreatic ductal adenocarcinoma (PDAC).

SECONDARY OBJECTIVE:

I. To assess safety and tolerability of the proposed therapy.

EXPLORATORY OBJECTIVE:

I. 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (OMO-103)	Biopsy Procedure	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.
Treatment (OMO-103)	Biospecimen Collection	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.
Treatment (OMO-103)	Computed Tomography	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.
Treatment (OMO-103)	Magnetic Resonance Imaging	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.
Treatment (OMO-103)	Myc Inhibitor 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.

Primary Outcome Measures

Name	Time	Method
Measurable change in tumor biology	Time 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events	Day 1 (i.e., start of study intervention) up to 30 days after last dose of study drug	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.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States