Malignant AscitesPhase 1SIM0388-101NCT07007988
A Phase I Study of SIM0388 in Participants With Malignant Ascites.
A Phase 1 study testing SIM0388 in people with Malignant Ascites, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- SIM0388
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, 200131
Jin Li, PHD, +8613761222111, jin.li@gobroadhealthcare.com
About this study
Official title: 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
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
Read the detailed description
The study starts with a dose escalation part followed by a dose expansion part. The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0388 peritoneal perfusion, and determine the Maximum tolerated dose (MTD) and/or the recommended dose(s) (RD) of SIM0388 peritoneal perfusion.
The primary objective of the dose expansion part is to evaluate the efficacy of SIM0388 intraperitoneal perfusion in the treatment of malignant ascites.
- Conditions
- Malignant Ascites
- Being tested
- SIM0388
- Keywords
- Malignant Ascites, Solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0388Drug
Abdominal perfusion
SIM0388Drug
Abdominal perfusion
| Study group | Role | What they receive |
|---|---|---|
| SIM0388 Dose escalation-mono | Experimental | Sequential cohorts of increasing dose levels of SIM0388 will be evaluated as monotherapy Receives: Drug: SIM0388 |
| SIM0388 Dose expansion | Experimental | Recommended Dose(s) of SIM0388 as determined from Dose escalation will be evaluated Receives: Drug: SIM0388 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation:Dose limited toxicity (DLT)
Dose-limiting toxicity(DLT)
Measured: DLT observation period (up to 35 days)
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.
Measured: Through study completion, an average of 2 years
Dose expansion phase：ORRa(Objective response rate in ascites)
Ascites ORRa assessed according to WHO criteria
Measured: Through study completion, an average of 2 years
Dose expansion phase：TTPa (Time to progress in ascites)
Ascites TTPa assessed according to WHO criteria
Measured: Through study completion, an average of 2 years
Dose expansion phase：PuFS (Puncture/drainage -free survival)
PuFS
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start24 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007988
- Sponsor's protocol ID
- SIM0388-101
- Acronym
- SIM0388-101
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07007988
- Acronym / sponsor ID
- SIM0388-101 / SIM0388-101
- Conditions
- Malignant Ascites
- Keywords
- Malignant Ascites, Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study starts with a dose escalation part followed by a dose expansion part. The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0388 peritoneal perfusion, and determine the Maximum tolerated dose (MTD) and/or the recommended dose(s) (RD) of SIM0388 peritoneal perfusion.
The primary objective of the dose expansion part is to evaluate the efficacy of SIM0388 intraperitoneal perfusion in the treatment of malignant ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM0388 Dose escalation-mono | Experimental | Drug: SIM0388Sequential cohorts of increasing dose levels of SIM0388 will be evaluated as monotherapy |
| SIM0388 Dose expansion | Experimental | Drug: SIM0388Recommended Dose(s) of SIM0388 as determined from Dose escalation will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0388Abdominal perfusion | Drug | SIM0388 Dose escalation-mono |
| SIM0388Abdominal perfusion | Drug | SIM0388 Dose expansion |
Primary outcome
Dose escalation:Dose limited toxicity (DLT)
Time frame: DLT observation period (up to 35 days)
Dose-limiting toxicity(DLT)
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 2 years
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Dose expansion phase：ORRa(Objective response rate in ascites)
Time frame: Through study completion, an average of 2 years
Ascites ORRa assessed according to WHO criteria
Dose expansion phase：TTPa (Time to progress in ascites)
Time frame: Through study completion, an average of 2 years
Ascites TTPa assessed according to WHO criteria
Dose expansion phase：PuFS (Puncture/drainage -free survival)
Time frame: Through study completion, an average of 2 years
PuFS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0388 in people with Malignant Ascites, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Li, PHD (+8613761222111, jin.li@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation:Dose limited toxicity (DLT) (time frame: DLT observation period (up to 35 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.