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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Shanghai Gobroad Cancer Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jin Li, PHD
jin.li@gobroadhealthcare.com
+8613761222111
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
Experimental: SIM0388 Dose escalation-mono
Sequential cohorts of increasing dose levels of SIM0388 will be evaluated as monotherapy
Experimental: SIM0388 Dose expansion
Recommended Dose(s) of SIM0388 as determined from Dose escalation will be evaluated
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Simcere Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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