PanTher Therapeutics
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).
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 pre…
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 partici…
PTM-101, an absorbable drug product containing paclitaxel