Tests PTM-101 with chemotherapy in pancreatic cancer that is not yet removable
Tests PTM-101 with chemotherapy in adults with locally advanced pancreatic cancer.
Plain-language title generated from the registry record
Registry title: PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
Where in Australia
- The AlfredMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PanTher Therapeutics
- Trial code
- NCT06673017
- Record updated
- 8 October 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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: 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; Currently enrolled in another investigational drug or device trial; Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator; 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; Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child.