A Phase I Study of SIM0388 in Participants With Malignant Ascites.
ConditionMalignant Ascites
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- SIM0388
- SIM0388
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov