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

Launched by JIANGSU SIMCERE PHARMACEUTICAL CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SIM0388 for patients with malignant ascites, which is a buildup of fluid in the abdomen often caused by cancer. The goal of the study is to see how safe and effective this treatment is, as well as how it behaves in the body. Participants will receive SIM0388 through a method called intraperitoneal perfusion, where the medication is delivered directly into the abdomen.

To be eligible for this trial, patients must be at least 18 years old and have advanced solid tumors that have not responded to standard treatments. They should also have moderate or more severe ascites confirmed by an ultrasound and a life expectancy of at least three months. Participants can expect close monitoring during the trial to check for any side effects and to assess how well the treatment is working. It's important to note that certain health conditions and previous treatments may exclude some patients from joining the study.

Gender

ALL

Eligibility criteria

• 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.