PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Inclusion Criteria

• Imaging consistent with primary PDAC (if PDAC is to be confirmed at study-mandated laparoscopy) or imaging consistent with primary PDAC with prior biopsy/cytology
• No radiographic or physical exam evidence of metastatic disease
• No prior chemo-, radio-, or surgical therapy for PDAC
• Acceptable laboratory values
• CA 19-9 <500 U/mL at baseline after biliary decompression
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Ability to provide informed consent
• No signs or symptoms of pancreatitis
• No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation
• Subjects with childbearing potential must agree to use adequate contraception throughout study participation

Exclusion Criteria

• Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening)
• Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)
• Known human immunodeficiency virus (HIV) or active viral hepatitis
• Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor
• Inability to comply with activities and therapeutic interventions as outlined in the schedule of events
• Currently enrolled in another investigational drug or device trial
• Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child
• Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator