Actively Recruiting
A Phase Ib, Open Label, Multicenter Study Evaluating Safety and Preliminary Efficacy of JMKX000197 Injection in Malignant Pleural Effusion
Led by Jemincare · Updated on 2025-04-04
30
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying malignant pleural effusion, a condition where fluid builds up around the lungs in patients with advanced solid tumors. This research is a Phase Ib clinical trial aiming to evaluate the safety, tolerance, how the body processes the drug, and preliminary effectiveness of JMKX000197 injection as a treatment option. The study also seeks to determine the recommended dose for future trials. Participants will receive either one of two doses of JMKX000197 injected into the pleural space or undergo tube thoracostomy drainage, a procedure to remove fluid from around the lungs. This open-label, randomized trial takes place at multiple centers and compares these interventions to understand their effects on malignant pleural effusion. During the study, participants will be closely monitored for adverse events and their response to treatment up to 36 days initially, with follow-up lasting up to 24 months to assess survival and fluid control. Pharmacokinetic testing will measure drug levels in the body during the first week. Researchers will collect various health data including overall survival, response of the pleural effusion, and how long patients remain free from needing drainage procedures.
CONDITIONS
Brief Title
A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and good compliance
- Age between 18 and 75 years, any gender
- Advanced solid tumor confirmed by histopathology or cytopathology
- Malignant pleural effusion confirmed or clinically diagnosed as moderate or above, requiring drainage
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Life expectancy of at least 3 months
- Adequate organ function
- Female participants of childbearing potential must agree to use contraception and have a negative pregnancy test before enrollment; male participants must also agree to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Bilateral pleural effusion or concurrent peritoneal or pericardial effusion
- Encapsulated or severely separated pleural effusion, chylothorax, or infectious pleural effusion
- Prior use of interferon gene stimulating factor (STING) agonists for pleural perfusion
- Known allergies to the study drug or its components
- Participation in other clinical trials within 28 days prior to randomization
- Major surgery within 28 days prior to randomization
- Central nervous system metastatic disease, leptomeningeal disease, or spinal cord compression
- Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, or seizure disorders
- Uncontrollable systemic infections including hepatitis B, hepatitis C, or HIV
- History of organ transplantation
- Any condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Up to approximately 36 days
Participants receive JMKX000197 injection via pleural perfusion or undergo tube thoracostomy drainage as part of the study treatment.
Multiple visits during treatment for drug administration and monitoring
Duration - Up to approximately 24 months
Participants are monitored for safety, efficacy, and survival outcomes following treatment.
Periodic visits over 24 months for follow-up assessments
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100017
Actively Recruiting
Research Team
F
Fawei Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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