Phase Ib Study of PTM-101 Combined with Neoadjuvant Chemotherapy for Untreated Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating PTM-101 combined with neoadjuvant chemotherapy in people newly diagnosed with borderline resectable or locally advanced pancreatic ductal adenocarcinoma PDAC. This phase Ib study aims to find the best dose of PTM-101 that is safe and to further assess its potential benefits for this group. The study is non-randomized, single-arm, and open-label, focusing on treatment-nafve patients. The study has two parts dose escalation and dose expansion. In the dose escalation phase, up to 12 participants will receive increasing doses of PTM-101 combined with standard neoadjuvant chemotherapy to determine the recommended dose for future studies, followed by at least 24 months of follow-up. In the dose expansion phase, up to 20 participants will receive PTM-101 at the recommended dose along with chemotherapy and be monitored for at least 24 months. Participants will undergo laparoscopy and provide informed consent before starting treatment. Researchers will monitor safety, drug levels, and treatment effects within 21 days and up to 24 months after PTM-101 placement. Assessments include laboratory tests, physical exams, and tracking of adverse events. The study aims to understand the safety and potential efficacy of PTM-101 combined with chemotherapy in this pancreatic cancer population.

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)