Phase IbIIa Study of MR001 With Chemotherapy for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma After First-line Therapy

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effects of a drug called MR001 combined with standard chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma PDAC who have worsened after their first treatment. This Phase IbIIa open-label study aims to understand how well MR001 works and how safe it is when given with chemotherapy to this patient group. The study involves giving MR001 intravenously once a week at different doses 2mgkg, 4mgkg, or 6mgkg combined with either Irinotecan Liposome plus leucovorin5-FU or nab-paclitaxel plus gemcitabine, following approved local dosing guidelines. Initially, patients participate in a dose-escalation phase to find the best dose and schedule, followed by a dose-expansion phase to further evaluate the chosen dose combination based on earlier results. Participants will be monitored over several months with assessments including tracking side effects, measuring drug levels in the blood, and evaluating tumor response using recognized criteria. The study will measure outcomes such as dose-limiting toxicities, maximum tolerated dose, response rates, progression-free survival, and overall survival. Blood tests will also assess immune system markers. The total monitoring period spans up to about 30 months, with safety and effectiveness evaluations throughout the study.

A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy