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

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