OMO-103 for advanced or metastatic pancreatic ductal adenocarcinoma

An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma

This trial tests an experimental IV drug called OMO-103 to see if it changes tumor cells in adults with locally advanced or metastatic pancreatic ductal adenocarcinoma.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OHSU Knight Cancer Institute (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT07089940 on ClinicalTrials.gov

What this trial studies

This is an early Phase 1 study of OMO-103, a Myc inhibitor given by IV on days 1 and 8 of each cycle, aimed at measuring its effects on pancreatic tumor biology. Participants will have pre- and post-treatment tumor biopsies, regular blood draws, and CT or MRI imaging to track changes. The study will collect safety data and look for biomarkers that predict which tumors respond. Patients are followed 30 days after treatment and then for one year to monitor outcomes.

Who should consider this trial

Good fit: Adults (≥18) with clinically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, ECOG 0-2, and at least one lesion that can be biopsied who can tolerate IV infusions and study procedures are ideal candidates.

Not a fit: Patients without biopsy-accessible disease, with ECOG >2, significant organ dysfunction, or other contraindications to biopsy or IV therapy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, OMO-103 could slow or stop tumor growth in some patients with advanced pancreatic cancer and help identify biomarkers to match patients to this therapy.

How similar studies have performed: Targeting Myc is a promising but largely experimental approach with limited clinical success to date and primarily preclinical supporting data for similar agents.

Eligibility criteria

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

Where this trial is running

Portland, Oregon

• OHSU Knight Cancer Institute — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Charles D Lopez — OHSU Knight Cancer Institute

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