Actively Recruiting
A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Led by Jemincare · Updated on 2025-04-04
30
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
CONDITIONS
Official 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...
- Participants aged 18 to 75 years, any gender
- Voluntarily joined the study and signed informed consent with good compliance
- Diagnosed with advanced solid tumors by histopathology or cytopathology
- Malignant pleural effusion confirmed by pathology or clinically diagnosed as moderate or above requiring drainage
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate organ function
- Female participants of childbearing potential agree to use contraception until 6 months after treatment and have a negative pregnancy test 7 days before enrollment; males agree to use effective contraception during the study and for 6 months after treatment
- Female participants must not be lactating
You will not qualify if you...
- Bilateral pleural effusion or concurrent peritoneal or pericardial effusion
- Pleural effusion that is encapsulated, severely separated, merged with chylothorax, or combined with infectious pleural effusion
- Previous use of interferon gene stimulating factor (STING) agonists for pleural perfusion
- Known allergy to the study drug or its components
- Participation in other clinical trials within 28 days before randomization
- Major surgery within 28 days before randomization
- Central nervous system metastatic disease, leptomeningeal disease, or spinal cord compression
- Clinically unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, or seizure conditions
- Uncontrollable systemic infections including positive tests for hepatitis B, C, HIV, or other infections requiring systemic treatment within 28 days before randomization
- History of organ transplantation
- Any condition deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100017
Actively Recruiting
Research Team
F
Fawei Wu
CONTACT
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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