SIM0388 intraperitoneal treatment for malignant ascites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I study delivers SIM0388, a docetaxel polymeric micelle formulation, directly into the peritoneal cavity to target malignant ascites. The protocol begins with a dose-escalation phase to determine safety, tolerability, maximum tolerated dose (MTD) and recommended dose(s), with pharmacokinetic sampling. A dose-expansion phase will then enroll additional patients at the recommended dose(s) to measure efficacy in controlling ascites and reducing symptom burden. Key outcomes include adverse events, ascites response (and need for paracentesis), and drug concentration profiles.

Why it matters

Who can join: the full rules

Inclusion 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 subjects agree to use adequate contraception.

Exclusion Criteria:

* 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 medication, QTcF interval \>470 ms, or uncontrolled hypertension.
* 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.

Where it's running

• Shanghai Gobroad Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jin Li, PHD
• Email: jin.li@gobroadhealthcare.com
• Phone: +8613761222111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.