PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Inclusion Criteria:

• Imaging consistent with primary PDAC (if PDAC is to be confirmed at study-mandatedlaparoscopy) 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 safetymonitoring, efficacy results or prevent the subject from study participation

• Subjects with childbearing potential must agree to use adequate contraceptionthroughout 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 ofcarcinoma in situ of the cervix, superficial non-melanoma skin cancers, orsuperficial bladder cancer that has been adequately treated, or stage 1 prostatecancer that does not require treatment or requires only treatment with luteinizinghormone-releasing hormone agonists or antagonists if initiated at least 30 daysprior 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 ofpancreatic tumor

• Inability to comply with activities and therapeutic interventions as outlined in theschedule of events

• Currently enrolled in another investigational drug or device trial

• Women who are pregnant or breastfeeding or who plan to become pregnant orbreastfeed; men who plan to donate sperm or conceive a child

• Any other medical or surgical conditions, including prior abdominal surgery, thatwould preclude safe laparoscopy or implantation in the opinion of the investigator