NCT07007988

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

An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of Intraperitoneal Perfusion With Docetaxel Polymeric Micelles for Injection in Patients With Malignant Ascites

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for injection in patients with malignant ascites

Detailed description

The study starts with a dose escalation part followed by a dose expansion part. The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0388 peritoneal perfusion, and determine the Maximum tolerated dose (MTD) and/or the recommended dose(s) (RD) of SIM0388 peritoneal perfusion. The primary objective of the dose expansion part is to evaluate the efficacy of SIM0388 intraperitoneal perfusion in the treatment of malignant ascites.

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DRUG	SIM0388	Abdominal perfusion
DRUG	SIM0388	Abdominal perfusion

Timeline

• Start date: 2025-04-24
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: China