Summary
This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).
Detailed Description
This is a multi-center, non-randomized, single-arm, open-label, phase Ib dose escalation/dose expansion study of PTM-101 in subjects with pancreatic ductal adenocarcinoma (PDAC). Dose escalation will assess the safety of PTM-101 containing escalating doses of paclitaxel to establish the preliminary Recommended Phase II Dose (RP2D) when combined with neoadjuvant chemotherapy for subjects who are treatment-naïve, have borderline resectable or locally advanced PDAC and are eligible for neoadjuvant chemotherapy. Subsequently, the dose expansion portion will expand the number of subjects at the preliminary RP2D to assess the efficacy of PTM-101.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology/cytology either at study-mandated laparoscopy or by prior 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 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. This criterion excludes 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). 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 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