A Phase Ib Dose Escalation/Dose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma [PDAC]. (NCT06673017)

This is a multi-centre, 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).

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

A/Prof Charles Pilgrim

Key inclusion data

Imaging consistent with primary borderline resectable (BR) or locally advanced Pancreatic Ductal Adenocarcinoma (PDAC). PDAC may be confirmed by histology/cytology either at study-mandated laparoscopy or by prior biopsy/cytology. Indicated for laparoscopy. Tumour size and anatomy amenable to PTM-101 placement per Investigator’s discretion based on imaging. No prior therapy of any kind for PDAC. No symptomatic pancreatitis.