Randomized Double-Blind Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 for Untreated Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are studying metastatic pancreatic ductal adenocarcinoma PDA in adults who have not been previously treated for this condition. The trial evaluates the effect of adding SBP-101, a small molecule polyamine metabolic inhibitor, to the standard chemotherapy regimen of gemcitabine and nab-paclitaxel. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival and other important outcomes in about 600 patients. Participants will receive either SBP-101 combined with nab-paclitaxel and gemcitabine or a placebo with the same chemotherapy drugs. The treatments are given as injections, and the study includes two groups one experimental arm receiving SBP-101 plus chemotherapy and one control arm receiving placebo plus chemotherapy. The safety and effectiveness of treatments will be monitored throughout the trial by an independent committee. During the study, patients will be followed for overall survival up to 100 weeks or until death. Researchers will also measure progression-free survival, responses seen on scans, and quality of life. Assessments include imaging with CT or MRI, blood tests, and monitoring of side effects. Participants must consent to the study and meet specific health criteria, and safety will be closely observed throughout the trial period.

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer