Phase I Study of Intraperitoneal Docetaxel Polymeric Micelles SIM0388 for Malignant Ascites Evaluating Safety, Efficacy, and Drug Characteristics

What this Trial Is About

Researchers are evaluating intraperitoneal perfusion with Docetaxel Polymeric Micelles SIM0388 for patients with malignant ascites, a common complication of malignant tumors. This phase I study aims to assess the safety, efficacy, and pharmacokinetic features of SIM0388 in this condition. The study includes both dose escalation and dose expansion parts to better understand the treatments effects and appropriate dosing. The trial begins with a dose escalation phase to determine the maximum tolerated dose and recommended doses of SIM0388 given via peritoneal perfusion. After establishing the dose, a dose expansion phase will evaluate the treatments effectiveness in managing malignant ascites. Participants receive sequential cohorts of increasing doses or the recommended doses of SIM0388 as monotherapy through abdominal perfusion. Participants will be monitored for safety, tolerability, and response to treatment over an average of two years. Assessments include observing dose-limiting toxicities, adverse events, objective response rate in ascites, time to progression in ascites, and puncturedrainage-free survival. The study involves regular evaluations including physical exams, imaging, laboratory tests, and monitoring of treatment effects to gather comprehensive data on SIM0388s impact.

A Phase I Study of SIM0388 in Participants With Malignant Ascites.