NCT07007988 A Phase I Study of SIM0388 in Participants With Malignant Ascites.
| NCT ID | NCT07007988 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
| Condition | Malignant Ascites |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-24 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-04-24 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07007988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Ascites. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07007988 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07007988 currently recruiting?
Yes, NCT07007988 is actively recruiting participants. Contact the research team at jin.li@gobroadhealthcare.com for enrollment information.
Where is the NCT07007988 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07007988 clinical trial?
NCT07007988 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. The trial plans to enroll 50 participants.