Treatment of malignant pleural effusion with JMKX000197 injection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerance, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JMKX000197 injection in patients with malignant pleural effusion. Participants will receive the injection along with tube thoracostomy drainage to manage their condition. The study aims to gather data on how well the treatment works and its effects on patients with advanced solid tumors. It is designed for individuals aged 18 to 75 who have been diagnosed with malignant pleural effusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
4. Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
6. Life expectancy of at least 3 months.
7. Adequate organ function.
8. 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 enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.

Exclusion Criteria:

1. Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
2. Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
3. Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
4. Known allergies to the study drug or its excipient components.
5. Have participated in other clinical trials within 28 days prior to randomization.
6. Major surgery within 28 days prior to randomization.
7. Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
8. Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
9. 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 randomization and require systemic anti-infective treatment.
10. Have a history of organ transplantation.
11. Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Principal investigator: Ning Li — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Fawei Wu
• Email: wufawei@jemincare.com
• Phone: +86 15720614080

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intrapleural TolueneSulfonamide in malignant pleural effusion: early safety and activity

  This study tests intrapleural injections of TolueneSulfonamide in adults with malignant pleural effusion to see if it is safe and could help reduce the effusion.

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• Air introduction during pleural effusion drainage for trapped lung

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• M701 treatment for malignant pleural effusions from advanced non-small cell lung cancer

  This trial tries M701 injected into the pleural space to see if it reduces fluid build-up and helps adults with stage IV NSCLC who have needed first-line treatment.

  Recruiting Phase 1/2 Wuhan YZY Biopharma Co., Ltd. · Hangzhou, Zhejiang · NCT05543330

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.