Phase 1b Study of S-1 With Nab-paclitaxel and Gemcitabine GAS for Adults With Metastatic Pancreatic Adenocarcinoma Dose Escalation and Expansion to Find Safe and Effective Doses

What this Trial Is About

This clinical trial investigates metastatic pancreatic adenocarcinoma, a form of advanced pancreatic cancer with a poor survival rate. Researchers aim to evaluate a combination treatment using S-1 along with nab-paclitaxel and gemcitabine, known as the GAS regimen. This Phase 1b study focuses on finding the best dose that patients can tolerate and assessing potential side effects and tumor response. The study involves escalating doses of the GAS regimen given in cycles every 14 days. Three dose levels will be tested, adjusting the amounts of gemcitabine and nab-paclitaxel while dosing S-1 based on body surface area. The trial includes dose escalation and expansion phases to establish the maximum tolerated dose and recommended dose for further studies. Participants will receive treatment in cycles and undergo regular tumor assessments through imaging to monitor cancer progression or side effects. Researchers will measure outcomes including dose-limiting toxicities, tumor response rates, safety profiles, survival times, and disease control over up to three years. Patients will be closely monitored throughout the study to evaluate treatment effects and safety.

Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma