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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SIM0388
DrugAbdominal perfusion
SIM0388
DrugAbdominal perfusion
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SIM0388 Dose escalation-monoExperimental treatment 1 intervention
Group B: SIM0388 Dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose escalation:Dose limited toxicity (DLT)
Dose-limiting toxicity(DLT)
Time frame
DLT observation period (up to 35 days)2
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Time frame
Through study completion, an average of 2 years3
Dose expansion phase：ORRa(Objective response rate in ascites)
Ascites ORRa assessed according to WHO criteria
Time frame
Through study completion, an average of 2 years4
Dose expansion phase：TTPa (Time to progress in ascites)
Ascites TTPa assessed according to WHO criteria
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov