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New treatment option for Malignant Pleural Effusions (Mpe)
Official title A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
ClinicalTrials.gov ID: NCT06740019
What this study is testing
What is JMKX000197?
JMKX000197 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant pleural effusions (mpe).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
- Age ≥ 18 years and ≤ 75 years old, regardless of gender.
- Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
You likely can't join if
- Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
- Known allergies to the study drug or its excipient components.
- Have participated in other clinical trials within 28 days prior to randomization.
- Major surgery within 28 days prior to randomization.
See the full eligibility criteria
- The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
- Age ≥ 18 years and ≤ 75 years old, regardless of gender.
- Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
- Life expectancy of at least 3 months.
- Adequate organ function.
- Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX000197. The serum pregnancy test result should be negative 7 days before...
- Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
- Known allergies to the study drug or its excipient components.
- Have participated 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 cord compression.
- Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
- Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive HBsAg and HBV DNA, positive HCV RNA, positive HIV antibody test or combined infections within the first 28 days of...
- Have a history of organ transplantation.
- Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.