PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
Trial Parameters
Brief 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).
Eligibility Criteria
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 o