OMO-103 for the Treatment of Locally 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 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.

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.

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