PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

Inclusion Criteria:

• Imaging consistent with primary borderline resectable or locally advanced PDAC. PDACmay be confirmed by histology/cytology either at study-mandated laparoscopy or byprior biopsy/cytology

• Indicated for laparoscopy

• No prior therapy of any kind for PDAC

• Acceptable laboratory values

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

• Ability to provide informed consent

• No symptomatic 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. This criterion excludes ahistory of carcinoma in situ of the cervix, superficial non-melanoma skin cancers,or superficial 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). Other potentially indolent cancers may be considered.

• 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 history of 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