A Phase I Study of SIM0388 in Participants With Malignant Ascites.
NCT ID: NCT07007988
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-04-24
2027-12-31
Brief Summary
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Detailed Description
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The primary objective of the dose expansion part is to evaluate the efficacy of SIM0388 intraperitoneal perfusion in the treatment of malignant ascites.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SIM0388 Dose escalation-mono
Sequential cohorts of increasing dose levels of SIM0388 will be evaluated as monotherapy
SIM0388
Abdominal perfusion
SIM0388 Dose expansion
Recommended Dose(s) of SIM0388 as determined from Dose escalation will be evaluated
SIM0388
Abdominal perfusion
Interventions
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SIM0388
Abdominal perfusion
SIM0388
Abdominal perfusion
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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.
18 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SIM0388-101
Identifier Type: -
Identifier Source: org_study_id
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