Actively Recruiting
A Phase I Study of SIM0388 in Participants With Malignant Ascites.
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-06-06
50
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase I Study of SIM0388 in Participants With Malignant Ascites.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 years or older, any gender
- Histologically or cytologically confirmed advanced or metastatic solid tumors
- Failure of at least one standard systemic anti-tumor therapy, unsuitability for standard therapy, or no standard therapy options
- Moderate or greater ascites confirmed by ultrasonography
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 3 months
- Adequate blood and organ function
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception; male subjects must also agree to use contraception
You will not qualify if you...
- Participation in another investigational study or use of investigational device within 4 weeks before first study dose
- Prior treatment with intraperitoneal paclitaxel-based therapy
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose or planned use during study
- Unrecovered adverse events from prior treatments above Grade 1
- Complete intestinal obstruction within 30 days before first dose
- Recent myocardial infarction within 6 months or unstable heart conditions including angina, cardiomyopathy, cerebrovascular events, heart failure, symptomatic coronary artery disease, arrhythmia, prolonged QTcF interval, or uncontrolled hypertension
- Uncontrolled primary brain tumors or central nervous system metastases
- Active infections including HIV, hepatitis B, or hepatitis C
- Known hypersensitivity to any component of SIM0388
- Pregnant or breastfeeding women
- Any medical or treatment condition that may interfere with study results or participant safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
Research Team
J
Jin Li, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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