SIM0388 intraperitoneal treatment for 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

This Phase I trial will test whether intraperitoneal Docetaxel polymeric micelles (SIM0388) can safely reduce malignant ascites in adults with advanced solid tumors who have exhausted or are not candidates for standard therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07007988 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced/metastatic solid tumors and moderate or greater malignant ascites who have failed, are unsuitable for, or lack standard systemic therapy options, with ECOG 0–2, life expectancy ≥3 months, and adequate organ and marrow function are eligible.

Not a fit: Patients with prior intraperitoneal paclitaxel therapy, significant organ dysfunction, pregnancy, recent participation in another investigational trial, or use of contraindicated strong CYP3A4 modulators are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, the treatment could reduce ascites accumulation, lower the need for repeat paracentesis, and improve symptoms and quality of life.

How similar studies have performed: Intraperitoneal taxane-based therapies have shown some symptom control for malignant ascites in prior work, but polymeric micelle formulations like SIM0388 are novel and have limited clinical data so far.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Gobroad Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jin Li, PHD

Conditions Malignant Ascites; Solid tumor