NCT06673017

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: PanTher Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Borderline Resectable Pancreatic Adenocarcinoma
• Locally Advanced Pancreatic Adenocarcinoma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	PTM-101	PTM-101, an absorbable drug product containing paclitaxel

Timeline

• Start date: 2025-04-14
• Primary completion: 2026-09-01
• Completion: 2028-06-01
• First posted: 2024-11-04
• Last updated: 2026-04-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study