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New treatment option for Malignant Ascites
Official title A Phase I Study of SIM0388 in Participants With Malignant Ascites.
ClinicalTrials.gov ID: NCT07007988
What this study is testing
What is SIM0388?
SIM0388 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant ascites.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary participation and signature of informed consent form;.
- ≥ 18 years of age, male or female.
- Participants with histologically and/or cytologically confirmed advanced/metastatic solid tumors;.
- Failure of at least one line of standard systemic anti-tumor therapy, unsuitability for standard systemic therapy, or absence of standard systemic...
- Moderate or greater ascites confirmed by ultrasonography
You likely can't join if
- Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks...
- Prior history of intraperitoneal paclitaxel-based therapy.
- Use of strong CYP3A4 inhibitors or inducers within 7 days before the first dose or anticipated use during the study.
- Failure to recover from adverse events caused by prior interventions to ≤Grade 1
- Complete intestinal obstruction within 30 days prior to the first dose.
- Myocardial infarction within 6 months, current unstable angina, primary cardiomyopathy, cerebrovascular events, congestive heart failure, symptomatic...
See the full eligibility criteria
- Voluntary participation and signature of informed consent form;.
- ≥ 18 years of age, male or female.
- Participants with histologically and/or cytologically confirmed advanced/metastatic solid tumors;.
- Failure of at least one line of standard systemic anti-tumor therapy, unsuitability for standard systemic therapy, or absence of standard systemic therapy options.
- Moderate or greater ascites confirmed by ultrasonography
- ECOG performance status of 0, 1or 2.
- Life expectancy ≥ 3 months.
- Adequate hematologic and organ function.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male people agree to use adequate contraception.
- Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment
- Prior history of intraperitoneal paclitaxel-based therapy.
- Use of strong CYP3A4 inhibitors or inducers within 7 days before the first dose or anticipated use during the study.
- Failure to recover from adverse events caused by prior interventions to ≤Grade 1
- Complete intestinal obstruction within 30 days prior to the first dose.
- Myocardial infarction within 6 months, current unstable angina, primary cardiomyopathy, cerebrovascular events, congestive heart failure, symptomatic coronary artery disease requiring medication, arrhythmia requiring...
- Uncontrolled primary brain tumors or CNS metastases.
- Active infection.
- Known history of HIV infection.
- Active hepatitis B or hepatitis C infection.
- Hypersensitivity to any active or inactive ingredient of SIM0388.
- Pregnant or lactating women.
- Any condition (medical history, disease, treatment, or lab abnormality) that may interfere with study results, impede full participation, or deemed by the investigator to contradict the subject's best interests.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.