RecruitingPhase 1NCT07007988

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

An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of Intraperitoneal Perfusion With Docetaxel Polymeric Micelles for Injection in Patients With Malignant Ascites

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

50 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Malignant ascites

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria13

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.