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.
• 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