Actively Recruiting
An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intraperitoneal Perfusion With Docetaxel Polymeric Micelles in Malignant Ascites
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-06-06
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 treatment's effects and appropriate dosing. The trial begins with a dose escalation phase to determine the maximum tolerated dose and recommended dose(s) of SIM0388 given via peritoneal perfusion. After establishing the dose, a dose expansion phase will evaluate the treatment's effectiveness in managing malignant ascites. Participants receive sequential cohorts of increasing doses or the recommended dose(s) 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 puncture/drainage-free survival. The study involves regular evaluations including physical exams, imaging, laboratory tests, and monitoring of treatment effects to gather comprehensive data on SIM0388's impact.
CONDITIONS
Brief 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
- Adults aged 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 available standard therapy options
- Moderate or greater ascites confirmed by ultrasound
- 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 participants 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 dose
- Prior intraperitoneal paclitaxel-based therapy
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose or anticipated use during the 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 cardiac conditions
- Uncontrolled primary brain tumors or central nervous system metastases
- Active infections including HIV, hepatitis B, or hepatitis C
- Known allergy to any component of SIM0388
- Pregnant or lactating women
- Any condition that may interfere with study results or participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 days
Participants receive escalating doses of SIM0388 through abdominal perfusion to evaluate safety, tolerability, and determine recommended dose(s).
Multiple visits during dose escalation period
Duration - Up to 2 years
Participants receive SIM0388 at the recommended dose(s) via abdominal perfusion to evaluate efficacy in treating malignant ascites.
Regular visits throughout treatment period
Duration - Up to 2 years
Participants are monitored for safety, adverse events, and efficacy outcomes after treatment completion.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
Research Team
J
Jin Li, PHD
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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