A Phase 1 interventional study of PTM-101 in Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, sponsored by PanTher Therapeutics. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by PanTher Therapeutics · Phase 1, Interventional, and Treatment
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 preliminary RP2D to assess the efficacy of PTM-101.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 26 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →This is the only study on the registry with PanTher Therapeutics as lead sponsor.
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Exclusion Criteria:
Dose escalation will follow a modified (3+3) design to establish the preliminary RP2D and characterize the safety and pharmacokinetic profile of PTM-101, which will be taken together with all prior clinical data to establish and characterize the preliminary RP2D. A maximum of 12 subjects with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101 combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.
Drug: PTM-101
The dose of PTM-101 will be the preliminary RP2D determined from all available clinical data. Up to 20 subjects, inclusive of those already assigned to the preliminary RP2D in the dose escalation part, with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101, combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months.
Drug: PTM-101
PTM-101, an absorbable drug product containing paclitaxel
Dose Escalation
Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0
Time frame: Within 21 days of PTM-101 placement
Dose Expansion
Safety: serious adverse events related to PTM-101 or PTM-101 placement
Time frame: Within 3 months of PTM-101 placement
Dose Expansion
Efficacy: volume response rate (VRR) of ≥ 40% reduction in tumor volume
Time frame: Within 3 months of PTM-101 placement
Dose Escalation and Dose Expansion
Overall response rate (ORR) by RECIST 1.1 and WHO
Time frame: At 21 days and 3 months post PTM-101 placement
Dose Escalation and Dose Expansion
Progression free survival (PFS) per RECIST 1.1
Time frame: Within 24 months of PTM-101 placement
Dose Escalation and Dose Expansion
Overall survival (OS)
Time frame: Within 24 months of PTM-101 placement
Plan to share: No
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