A Phase I Study of SIM0388 in Participants With Malignant Ascites.

NCT07007988 | Recruiting Phase 1

• 1 other identifier: SIM0388-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malignant Ascites

Keywords

Malignant Ascites; Solid tumor

Outcome Measures

Primary Outcomes (5)

• Dose escalation:Dose limited toxicity (DLT)

  Dose-limiting toxicity(DLT)

  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.

  Through study completion, an average of 2 years

• Dose expansion phase：ORRa(Objective response rate in ascites)

  Ascites ORRa assessed according to WHO criteria

  Through study completion, an average of 2 years

• Dose expansion phase：TTPa (Time to progress in ascites)

  Ascites TTPa assessed according to WHO criteria

  Through study completion, an average of 2 years

• Dose expansion phase：PuFS (Puncture/drainage -free survival)

  PuFS

  Through study completion, an average of 2 years

Study Arms (2)

SIM0388 Dose escalation-mono

EXPERIMENTAL

Sequential cohorts of increasing dose levels of SIM0388 will be evaluated as monotherapy

Drug: SIM0388

SIM0388 Dose expansion

EXPERIMENTAL

Recommended Dose(s) of SIM0388 as determined from Dose escalation will be evaluated

Drug: SIM0388

Interventions

SIM0388 DRUG

Abdominal perfusion

SIM0388 Dose escalation-mono

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Gobroad Cancer Hospital

Shanghai, Shanghai Municipality, 200131, China

RECRUITING

Central Study Contacts

Jin Li, PHD

CONTACT

+8613761222111; jin.li@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 6, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)